[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hairy-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hairy-cell-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,76,99,121,149,172,199,230,252,279],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645065","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-hematologic-malignancies-100645065",false,"NCT07679919","BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","A Phase 1 Study of Allogeneic (γ\u002Fδ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies","Inclusion Criteria:\n\n1\\. Male or female 18-75 years of age. 2. Patient with:\n\na. NHL: Histologically confirmed B cell NHL (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma, MCL, marginal zone lymphoma (MZL)) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT), and iii. Measurable disease per Lugano Revised Response Criteria for Malignant Lymphoma\n\nor\n\nb. CLL: histologically confirmed CLL i. Relapsed after 2 or more lines of therapy ii. Previous therapies prescribed must have included a Bruton's tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL2) inhibitor, iii. Measurable disease and active disease: Active disease as defined by the iwCLL criteria, meeting at least one of the following criteria:\n\n1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and\u002For thrombocytopenia. Cutoff levels of Hb \\\u003C10 g\u002FdL or platelet counts \\\u003C100 × 10\\^9\u002FL are generally regarded as indication for treatment.\n2. Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.\n3. Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.\n4. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine, etc.).\n5. Disease-related symptoms as defined by any of the following:\n\n   1. Unintentional weight loss ≥10% within the previous 6 months.\n   2. Significant fatigue (i.e., Eastern Cooperative Oncology Group (ECOG) performance scale 2 or worse; cannot work or unable to perform usual activities).\n   3. Fevers ≥ 38.0°C for 2 or more weeks without evidence of infection.\n   4. Night sweats for ≥1 month without evidence of infection.\n\nor\n\nc. HCL: histologically confirmed HCL i. Relapsed after at least one line of therapy, which must have included a purine nucleoside (eg. fludarabine, cladribine or pentostatin) and moxetumomab pasudotox.\n\nii. Need for treatment as evidenced by any one of the following: Absolute Neutrophil Count (ANC) \\\u003C1 × 10\\^3\u002FmcL, Hb \\\u003C10g\u002FdL, platelet count \\\u003C100 × 10\\^3\u002FmcL, leukemia cell count \\>5 × 10\\^3\u002FmcL, symptomatic splenomegaly, or enlarging HCL mass \\>2 cm in short axis.\n\nor\n\nd. MM: histologically confirmed MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\nii. Measurable disease per IMWG uniform response criteria 3. Adequate organ function as defined by:\n\n1. Creatinine clearance more than or equal to 45 ml\u002Fmin calculated by the Cockcroft - Gault formula\n2. Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.\n3. Adequate pulmonary function with pulse oximetry ≥ 92% on room air.\n4. Total Bilirubin \\\u003C 1.5× the institutional upper limit of normal (\\\u003C2.5× if caused by the baseline cancer and in patients with Gilbert's syndrome).\n5. Alanine aminotransferase (ALT (Serum Glutamic-Pyruvic Transaminase (SGPT))) and Aspartate Aminotransferase (AST (Serum Glutamic-Oxaloacetic Transaminase (SGOT) \\\u003C 2.5× the institutional upper limit of normal.\n\n   4\\. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n\n   5\\. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration\n\nof the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n6\\. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after CAR-T cell infusion to avoid potential embryonal or fetal exposure.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n7\\. Body weight of at least 55kg for patients treated at dose level 3 (450 × million BAFF+ CAR cells) and at least 37kg for all other dose levels.\n\nExclusion Criteria:\n\n1. Second active (i.e., currently requires antineoplastic therapy) non-B cell lineage malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast).\n2. Renal failure requiring regular dialysis.\n3. Uncontrolled pulmonary disease or infection.\n4. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n5. Active infection requiring systemic treatment.\n6. HIV seropositive with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months of enrollment, or has not been on an established antiretroviral therapy (ART) for at least four weeks with an HIV viral load less than 400 copies\u002FmL.\n7. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test.\n8. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n9. Patients with history of clinically relevant central nervous system (CNS) pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.\n10. Subjects with uncontrolled intercurrent or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Patients receiving a live vaccine within 2 weeks prior to screening.\n12. Concurrent use of high dose systemic steroids and\u002For immunosuppressive therapies.\n\n    1. Steroid dose must be weaned to ≤10 mg\u002Fday prednisone equivalent prior to CAR-T cell infusion.\n    2. Immunosuppressive medications must be stopped at least 5 half-lives prior to CAR-T cell infusion.","ALL","18 Years","75 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory hematologic malignancies, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.",[27,28,29,30],"Non-Hodgkin Lymphoma","Chronic Lymphocytic Leukemia","Hairy Cell Leukemia","Multiple Myeloma",[32,33],"Lymphoma","B-cell","NOT_YET_RECRUITING","2026-06-25",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2029-04",{"name":44,"class":45},"Luminary Therapeutics","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100387257","phase-2-binimetinib-for-people-with-relapsedrefractory-braf-wild-type-hairy-cell-leukemia-and-variant-100387257","NCT04322383","Binimetinib for People With Relapsed\u002FRefractory BRAF Wild Type Hairy Cell Leukemia and Variant","Phase 2 Trial for Binimetinib for Patients With Relapsed\u002FRefractory BRAF Wild Type Hairy Cell Leukemia and Variant","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of HCL or HCLv according to morphological and immunophenotypic criteria of World Health Organization (WHO) classification \\[WHO, 2008 revised 2016\\] of lymphoid neoplasm. Participants should have at least one of the following indications for therapy:\n\n  * Absolute neutrophil count (ANC) \\\u003C1 x10\\^3\u002FmcL\n  * Hemoglobin \\\u003C10g\u002FdL\n  * Platelets\\\u003C100 x10\\^3\u002FmcL\n  * Symptomatic splenomegaly\n  * Enlarging HCL mass or bone lesion \\> 2cm in short axis\n  * Leukemia cell count \\>5x10\\^3\u002FmcL\n  * Leukemic doubling time \\\u003C6 months\n\nParticipants who have eligible blood counts within 4 weeks prior to initiation of study therapy will not be considered ineligible if subsequent blood counts prior to initiation of study therapy fluctuate and become ineligible up until the time of the initiation of study therapy.\n\n* Refractory or relapsed disease - defined as either:\n\n  * Refractory- no response or disease progression in less than or equal to 1 year following first-line treatment with a purine analog, or\n  * Relapsed- having relapsed following treatment with at least 1 prior purine-analog treatments\n* Participants must be BRAF WT as confirmed from fresh bone marrow aspirate and\u002For peripheral blood sample, or lymph node\u002Fmass by the Laboratory of Pathology, NCI\n* Participants who are ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo or have failed Moxetumomab Pasudotox trial at NCI\n* Age greater than or equal to 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60 percent).\n* Adequate organ and marrow function as defined below:\n\n  * Total bilirubin less than or equal to 3x upper limit of normal (ULN), unless consistent with Gilbert s (ratio between total and direct bilirubin \\> 5)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x ULN\n  * Alkaline phosphatase \\\u003C= 5x ULN\n  * Serum creatinine less than or equal to 1.5 mg\u002FdL or creatinine clearance greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using estimated glomerular filtration rate (eGFR)\n  * Serum albumin greater than or equal to 2 g\u002FdL\n  * Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) \\\u003C 2.5x ULN (If on warfarin, PT\u002FINR \\\u003C 3.5x ULN; If on any other anticoagulation, Prothrombin time (PT) \\\u003C 2.5x ULN\n  * Fibrinogen greater than or equal to 0.5x lower limit of normal\n* The effects of binimetinib on the developing human fetus are unknown therefore participants must use effective methods of contraception as directed below.\n* Females of childbearing potential (FOCBP) who are sexually active with a nonsterilized male partner must use a highly effective method of contraception and not donate ova prior to study entry and or the duration of study treatment and until 30 days after the last dose of binimetinib. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are premenarchal or postmenopausal (defined as 12 months with no menses without an alternative medical cause). A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Not all methods of contraception are highly effective. Female subjects must use a hormonal method in addition to a barrier method alone, to minimize the chance of pregnancy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Non-sterilized male participants who are sexually active with a female partner of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, and not donate sperm from study entry until 90 days after the last dose of binimetinib.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 days after the last dose of the study drug.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Must co-enroll in study 10-C-0066: Collection of Human Samples to Study Hairy Cell and other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment\n\nEXCLUSION CRITERIA:\n\n* Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks prior to the start of study treatment.\n* Prior therapy with binimetinib.\n* Participants who are receiving any other investigational agents or have received an investigational agent within 14 days prior to the start of study treatment.\n* Participants who have undergone major surgery less than or equal to 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure.\n* Known hypersensitivity or contraindication to any component of binimetinib or its excipients.\n* Inability to swallow and retain study drug.\n* Pregnant women as evaluated by a positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac disfunction (details as below), uncontrolled pulmonary infection, pulmonary edema or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Evidence of active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n\nNote: Participants with laboratory evidence of cleared HBV or HCV infection may be enrolled. If positive for Hepatitis B core antibody or surface antigen, the participant must be on Tenofovir or Entecavir and Hepatitis B deoxyribonucleic acid (DNA) viral load (VL) must be \\\u003C2000 IU\u002FmL\n\n* Active second malignancy requiring treatment other than minor resection of indolent cancers like basal cell and squamous skin cancers.\n* Human immunodeficiency virus (HIV)-positive participants unless taking appropriate anti- HIV medications with a CD4 count of \\> 200. Otherwise, there may be an increased risk of infections.\n* History of an allogeneic bone marrow or stem cell transplant.\n* Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) \\\u003C 3 months prior to initiation of study therapy;\n  * Congestive heart failure requiring treatment (New York Heart Association Grade greater than or equal to 2);\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50 percent as determined by multigated acquisition scan (MUGA) or transthoracic echocardiogram (TTE);\n  * Uncontrolled hypertension defined as persistent systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg despite current therapy;\n  * History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Triplicate average baseline QTcF interval greater than or equal to 480 ms.\n* Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (less than or equal to 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.\n* Concurrent neuromuscular disorder that is associated with elevated creatinine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of maculopathy or retinopathy for which there is an increased risk of\n\nMEK induced exudation (e.g., Central Serous Retinopathy).\n\n-History of thromboembolic or cerebrovascular events less than or equal to 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli.\n\nNote: Participants with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks.\n\nNote: Participants with thromboembolic events related to indwelling catheters or other procedures may be enrolled.",{"count":55,"type":21},40,[57],"PHASE2","Background:\n\nMost people with hairy cell leukemia have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. We found that in hairy cell leukemia, when BRAF is not mutated, the MEK gene frequently is. Binimetinib is a MEK inhibitor which targets MEK. It is important to determine if this drug can be a good treatment option in those who cannot benefit treatment with BRAF inhibitors.\n\nObjective:\n\nTo see if binimetinib is an effective treatment for hairy cell leukemia that does not have a BRAF mutation.\n\nEligibility:\n\nPeople ages 18 and older with hairy cell leukemia without a mutation in the BRAF gene and whose disease either did not respond to treatment or came back after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Lung and heart tests\n* Eye exam\n* Bone marrow biopsy: A needle will be injected through the participant s skin into the bone to remove a sample of marrow.\n* CT or MRI scan: Participants will lie in a machine that takes pictures of the body. They might receive a contrast agent by vein.\n\nBefore they start treatment, participants will have an abdominal ultrasound, pulmonary function tests, and exercise stress tests.\n\nParticipants will take binimetinib by mouth twice daily in 28-day cycles. They will keep a medication diary.\n\nParticipants will have at least one visit before every cycle. Visits will include repeats of some screening tests.\n\nParticipants may continue treatment as long as their disease does not get worse and they do not have bad side effects.\n\nAbout a month after their last dose of treatment, participants will have a follow-up visit. They will then have visits once a year....",[29],[61,62,63,64],"MEK1","Inhibitor","MEK2","MEK162","RECRUITING","2026-06-17",{"date":68,"type":38},"2026-06-18",{"date":70,"type":38},"2021-01-07",{"date":72,"type":21},"2028-07-31",{"name":74,"class":75},"National Cancer Institute (NCI)","NIH",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"100088621","phase-2-cladribine-and-rituximab-in-treating-patients-with-hairy-cell-leukemia-100088621","NCT00412594","Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia","Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination\n* Patients with relapsed disease are eligible if they have had no more than one prior therapy\n* Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study\n* Performance status =\\\u003C 3\n* Creatinine less than or equal to 2.0 unless related to the disease\n* Bilirubin less than or equal to 3.0\n* Transaminases less than or equal 3 x upper limit of normal unless related to the disease\n* No prior investigational agent in the 4 weeks prior to initiation of therapy\n\nExclusion Criteria:\n\n* Unable or unwilling to sign the consent form\n* Known infection with human immunodeficiency virus (HIV), hepatitis B or C\n* Presence of active infection\n* Presence of central nervous system (CNS) metastases\n* New York Heart Association classification III or IV heart disease\n* Prior chemotherapy (last 4 weeks)",{"count":84,"type":21},150,[57],"This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.",[29,88],"Recurrent Hairy Cell Leukemia","2026-06-09",{"date":91,"type":38},"2026-06-11",{"date":93,"type":38},"2004-06-10",{"date":95,"type":21},"2027-06-30",{"name":97,"class":98},"M.D. Anderson Cancer Center","OTHER",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100590261","phase-1-testing-the-combination-of-anti-cancer-drugs-tovorafenib-plus-rituximab-in-patients-with-hairy-cell-leukemia-100590261","NCT06965114","Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia","A Phase 1 Study of Combination Tovorafenib (DAY101) and Rituximab Treatment in Relapsed or Refractory Classical Hairy Cell Leukemia and Phase 2 Randomized Study Comparing Tovorafenib (DAY101) and Rituximab With Cladribine and Rituximab for Front-Line Treatment of Classical Hairy Cell Leukemia","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of classical hairy cell leukemia (HCL), including demonstration of BRAF V600E mutation by immunohistochemistry, molecular diagnostic testing, or polymerase chain reaction (PCR)\n* PHASE 1 ONLY: Prior therapy with at least one purine nucleoside analog-containing regimen (fludarabine, pentostatin, or cladribine) unless contraindicated. Prior vemurafenib alone is allowed in the relapsed\u002Frefractory cohort\n* PHASE 2 ONLY: No prior HCL-directed treatment for front-line cohort. The design of this cohort is such that the patients will need to be treatment naïve\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of tovorafenib (DAY101) or cladribine in combination with rituximab in patients \\\u003C 18 years of age, children are excluded from this study\n* Patients must meet indications for treatment of cHCL:\n\n  * Absolute neutrophil count \\\u003C 1,000\u002FmcL\n  * Platelets \\\u003C 100,000\u002FmcL\n  * Hemoglobin \\\u003C 10 g\u002FdL\n  * Recurrent infections\n  * Symptomatic and\u002For progressive extramedullary disease including lymph nodes and bone lesions\n  * Progressive or symptomatic splenomegaly or hepatomegaly\n  * Disease-related constitutional symptoms consisting of unexplained weight loss exceeding 10% body weight during the preceding 6 months, Cancer Therapy Evaluation Program (CTEP) active version of the Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 fatigue, and\u002For fever \\> 100.5 F or night sweats for \\> 2 weeks without evidence of active infection\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%); ECOG performance status \\> 2 (Karnofsky \\\u003C 60%) will be allowed if considered due to HCL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless related to Gilbert's disease or HCL; patients with documented Gilbert's disease may be enrolled with sponsor approval provided total bilirubin is ≤ 2.0 x ULN)\n* Creatinine clearance (ClCr) ≥ 30 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load for \\> 6 months\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \\\u003C 480 msec\n* The effects of tovorafenib (DAY101), cladribine, and rituximab on the developing human fetus are unknown. For this reason and because BRAF kinase inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use two forms of adequate contraception (including a highly effective birth control method in addition to a barrier method) during treatment prior to study entry and for the duration of study treatment participation and 12 months after the last dose of the study medication\n\n  * WOCBP should use effective non-hormonal contraception during treatment and for 12 months after the last dose of the study medication. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. For male patients with a female partner of childbearing potential, a condom should be used for contraception in addition to one of the highly effective contraception methods prior to the study, for the duration of study treatment, and 12 months after the last dose of the study medication. Male patients must not father a child or donate sperm while participating in this study\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LARs) may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Central nervous system (CNS) involvement with HCL is very rare, and therefore the biology of the disease in patients with CNS involvement may not be representative of the disease under study as a whole. Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n* Patients with HCL who are BRAF V600E mutation negative and those with the variant HCL\n* Patients with platelets \\\u003C 50,000\u002FmCL\n* Patients on warfarin and direct oral anticoagulants (due to risk of bleeding)\n* Patients who have not recovered from AEs as a result of prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Patients who are receiving strong CYP2C8 inhibitors, inducers, and breast cancer resistance protein (BCRP) substrates with narrow therapeutic index\n* Patients who are pregnant, breastfeeding, and\u002For unwilling to use adequate contraception during the study period and for 12 months after completion of the study\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to tovorafenib (DAY101) or other agents used in the study, including those with a previous history of severe infusion-related reaction (anaphylaxis) with rituximab administration\n* Patients with known hypersensitivity to any of the study drugs\n* Patients with an inability to swallow oral medications or with gastrointestinal impairment\n* Live or live-attenuated vaccines within 28 days of randomization\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because tovorafenib (DAY101) is a BRAF kinase inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tovorafenib (DAY101), breastfeeding should be discontinued if the mother is treated with tovorafenib (DAY101). These potential risks may also apply to other agents used in this study",{"count":107,"type":21},84,[24,57],"This phase I\u002FII trial tests the safety, side effects, and effectiveness of tovorafenib in combination with rituximab in patients with classical hairy cell leukemia (cHCL) that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory) and compares the effect of tovorafenib and rituximab to current standard treatment of cladribine and rituximab in cHCL patients that have not yet received treatment. Tovorafenib blocks certain proteins made by the mutated BRAF gene, which may help keep cancer cells from growing. It is a type of kinase inhibitor. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cladribine damages the cell's deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Giving tovorafenib in combination with rituximab may be safe and tolerable and more effective than cladribine with rituximab in treating patients with untreated, recurrent or refractory cHCL.",[29,88,111],"Refractory Hairy Cell Leukemia","2026-06-02",{"date":114,"type":38},"2026-06-03",{"date":116,"type":38},"2026-05-29",{"date":118,"type":21},"2030-03-01",{"name":74,"class":75},4,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100559225","phase-2-a-study-of-vemurafenib-and-obinutuzumab-compared-to-cladribine-and-rituximab-in-people-with-hairy-cell-leukemia-hcl-100559225","NCT06561360","A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)","A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically confirmed classical HCL by the enrolling institution\n* Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.\n* Has not received any prior therapy for the disease\n* Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K\n* ECOG performance status of 0 - 2\n* Acceptable pre-study organ function during screening as defined as:\n\n  * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in patients with known Gilbert's syndrome who may be enrolled if direct bilirubin ≤ 3 x ULN);\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN; and\n  * Serum creatinine ≤ 1.5x ULN\n* Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of \\\u003C 480 msec\n* For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib and cladribine, and 18 months after discontinuation of rituximab and obinutuzumab\n* For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib\n* Negative serum pregnancy test within 7 days of commencement of treatment in women of childbearing potential\n\nExclusion Criteria:\n\n* Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.\n* Known hypersensitivity to any of the study drugs.\n* Patients with known long QT syndrome or uncorrectable electrolyte abnormalities\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n* Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody\n\n  ° Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \\[HBcAb\\] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing and take HBV viral prophylaxis such as entecavir.\n* Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)\n* Active uncontrolled infection, e.g. persistent bacteremia, supplemental oxygen or pressor supports, etc.\n* Live vaccination within 28 days of randomization\n* Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I\u002FII cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Patients with HCL variant (as defined by absence of expression of CD25)\n* Pregnant or lactating, or intending to become pregnant during the study",{"count":129,"type":21},86,[57],"The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.",[29],[134,135,136,137,138],"Vemurafenib","Obinutuzumab","Cladribine","Rituximab","24-160","2026-05-22",{"date":141,"type":38},"2026-05-26",{"date":143,"type":38},"2024-09-09",{"date":145,"type":21},"2027-09-09",{"name":147,"class":98},"Memorial Sloan Kettering Cancer Center",10,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":46},"100425088","phase-1-phase-i-study-of-anti-cd22-chimeric-receptor-t-cells-in-patients-with-relapsedrefractory-hairy-cell-leukemia-and-variant-100425088","NCT04815356","Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed\u002FRefractory Hairy Cell Leukemia and Variant","* INCLUSION CRITERIA\n* Histologically confirmed diagnosis of HCL or HCLv according to morphological and immunophenotypic criteria of WHO classification \\[WHO, 2008 revised 2016\\] of lymphoid neoplasm.\n* Participants should have any of the following indications for therapy:\n\n  * ANC \\\u003C1\u002FnL,\n  * Hemoglobin \\\u003C10g\u002FdL,\n  * Platelets\\\u003C100\u002FnL,\n  * Symptomatic splenomegaly,\n  * HCL mass with short axis \\> 2 cm outside or \\>0.5 cm inside the CNS,\n  * HCL\u002FHCLv count \\>5\u002FnL in blood or \\>25\u002Fmm\\^3 in CSF,\n  * HCL\u002FHCLv count doubling time \\\u003C6 months and increasing lytic or blastic bone lesions\n\nParticipants who have eligible blood counts within 4 weeks from the initiation of study will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment.\n\n* HCL\u002FHCLv, after prior treatment with, ineligible for, refusal of, or inability to obtain 1)rituximab given concurrently with or sequentially after purine analog, 2) moxetumomab pasudotox-tdft, and 3) BRAF-inhibition.\n* CD22 expression must be detected on greater than 80% of malignant cells by flow cytometry.\n* Participants must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease (MRD) detected by flow cytometry or immunohistochemistry.\n* Age \\>=18 years\n* ECOG performance \\\u003C=2 (Karnofsky \\>=60%, see Appendix A), participants are exempt from this criterion if poor performance status is related to HCL.\n* Participants must have adequate organ function as defined below: Participants must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met. If participants exhibit minor lab abnormalities that are determined to be related to HCL (not therapy-related), then those participants will be allowed to participate\n\n  * Total bilirubin \\\u003C= 3 ULN, unless consistent with Gilbert s (ratio between total and direct bilirubin \\> 5)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 3x upper limit of normal (ULN)\n  * Alkaline phosphatase \\\u003C 2.5 ULN\n  * Serum creatinine \\\u003C= 1.5 mg\u002FdL or creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR or measured\n  * Serum albumin \\> 2 g\u002FdL\n* Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) \\\u003C 2.5x ULN (if on warfarin, PT\u002FINR \\\u003C 3.5x ULN; If on any other anticoagulation, PT \\\u003C 2.5x ULN\n* Fibrinogen \\>= 0.5x lower limit of normal\n* Participants with CNS disease are eligible, with exceptions\n* Participants with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents for at least 30 days prior to initiation of study intervention.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception (barrier, hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy or 4 months after cells infusion, whichever is later.\n\nMen must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 4 months after the last dose of study drug.\n\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 4 months after the last dose of study drug.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n* Pregnancy\n* Systemic chemotherapy, immunotherapy, or radiation therapy \\\u003C= 2 weeks prior to apheresis with the following exception:\n\n  * Participants receiving steroids may be enrolled, provided there has been no increase in dose for at least 1 week prior to starting apheresis;\n  * For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment (including CNS radiation), with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the participant has measurable\u002Fevaluable disease outside the radiation port.\n* Other anti-neoplastic investigational agents, or antibody-based therapies currently or within 2 weeks prior to apheresis\n* Participants taking warfarin\n* Prior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of \\>= 5% by flow cytometry)\n* Seropositive for human immunodeficiency virus (HIV) antibody. (Participants with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy in the future should study results indicate effectiveness.)\n* Seropositive for hepatitis C virus (HCV) or positive for hepatitis B surface antigen (HbsAG). Participants who convert to negative will not be excluded for history of positive test.\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, asthma, chronic obstructive pulmonary disease, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells (i.e., gentamicin)",{"count":20,"type":21},[24],"Background:\n\nCAR (Chimeric Antigen Receptor) T cell therapy is a type of cancer treatment in which a person s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells. Researchers want to see if this treatment can help people with hairy cell leukemia (HCL).\n\nObjective:\n\nTo test whether it is safe to give anti-CD22 CAR T cells to people with HCL.\n\nEligibility:\n\nAdults ages 18 and older with HCL (classic or variant type) who have already had, are unable to receive, or have refused other standard treatments for their cancer.\n\nDesign:\n\nParticipants will be screened with the following:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nBiopsy sample\n\nElectrocardiogram\n\nEchocardiogram\n\nLung function tests\n\nImaging scans\n\nSome screening tests will be repeated during the study.\n\nParticipants may need to have a catheter placed in a large vein.\n\nParticipants will have magnetic resonance imaging of the brain.\n\nParticipants will have a neurologic evaluation and fill out questionnaires.\n\nParticipants will have leukapheresis. Blood will be removed from the participant. A machine will divide whole blood into red cells, plasma, and lymphocytes. The lymphocytes will be collected. The remaining blood will be returned to the participant.\n\nParticipants will get infusions of chemotherapy drugs.\n\nParticipants will get an infusion of the anti-CD22 CAR T cells. They will stay at the hospital for 14 days. Then they will have visits twice a week for 1 month.\n\nAfter treatment, participants will be followed closely for 6 months, and then less frequently for at least 5 years. Then they will have long-term follow-up for 15 years.",[29,159],"Hairy Cell Leukemia Variant",[161,162,163],"CD-22 Expressing Tumor","Chimeric Antigen Receptor","Adoptive Immunotherapy","2026-05-02",{"date":166,"type":38},"2026-05-05",{"date":168,"type":38},"2022-05-23",{"date":170,"type":21},"2036-12-01",{"name":74,"class":75},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":120},"100422047","phase-1-study-of-oral-administration-of-lp-168-in-patients-with-relapsed-or-refractory-b-cell-malignancies-100422047","NCT04775745","Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.","A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria:\n\n* Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.\n* Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.\n* Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:\n\n  * Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n* Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:\n\n  * Absolute Neutrophil Count (ANC) ≥1000\u002FuL;\n  * An exception is for subjects with an ANC\\\u003C1000\u002FuL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.\n  * Platelet count ≥ 50,000\u002FµL - OR - Platelet count ≥ 20,000\u002F µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)\n  * Hemoglobin ≥8.0g\u002FdL, and can be achieved by transfusion\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n* Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n  * Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;\n  * Any investigational therapy, including targeted small molecule agents.\n  * For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n* Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.\n* Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:\n\n  * Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti-neoplastic intent (except as noted in exclusion criteria #3);\n  * Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors.\n  * Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n* Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:\n\n  * Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study\n  * If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.\n  * If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n* Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.\n* Serum amylase \\> 1.5 × ULN or serum lipase \\> 1.5 × ULN.\n* Subject has any history of Richter's transformation for Phase 1a portion of the trial.\n* Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n* Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the cervix uteri;\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n* Subject requires anticoagulation with Warfarin.",{"count":180,"type":21},60,[24],"This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.",[184,185,186,187,188,189,29],"CLL\u002FSLL","Waldenstrom Macroglobulinemia","Follicular Lymphoma","Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","2026-02-10",{"date":192,"type":38},"2026-02-13",{"date":194,"type":38},"2021-07-19",{"date":196,"type":21},"2027-12-31",{"name":198,"class":45},"Newave Pharmaceutical Inc",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":46},"100542274","phase-1-autologouscd22-chimeric-antigen-receptor-cart-cells-in-wrecurrentrefractory-b-cell-lymphomas-100542274","NCT06340737","AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w\u002FRecurrent\u002FRefractory B Cell Lymphomas","Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas","Inclusion Criteria:\n\n* Disease: Must have histologically confirmed disease as defined by WHO 2016\\[117\\] of one of the following:\n\nFollicular Lymphoma, grade 1-3a\n\n1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.\n2. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.\n\nMantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.\n\n2\\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.\n\nHairy cell leukemia (HCL)\n\n1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \\\u003C11 g\u002FdL), thrombocytopenia (platelets\\\u003C100 x 10\\^9 \u002FL), or neutropenia (absolute neutrophil count below 1.5 x 10\\^9\u002FL); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;\n2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.\n\nLymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed\n\n1\\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy\n\n1\\. Prior therapies must include a i. BTKi ii. either chemotherapy and\u002For proteasome inhibitor 3. Requires treatment based on the recommendations from the Second International Workshop on WM 4. Requires the presence of serum IgM that is at least 2 times the upper limit of normal 5. Patients cannot require plasmapheresis for symptomatic hyperviscosity. 6. Patients cannot have symptomatic central nervous system involvement (Bing-Neel syndrome) that would prevent the assessment of neurotoxicity 7. Patients cannot have transformed to large B cell lymphoma Burkitt lymphoma (BL)\n\n1\\. Relapsed or refractory to front line chemoimmunotherapy; Participants with high-grade B-cell lymphoma with MYC and BCL2 and\u002ForBCL6 rearrangements will be excluded.\n\nMarginal zone lymphoma (MZL)\n\n1\\. Must have received 2 prior lines of therapy including rituximab in combination with chemotherapy or a BTKi\n\nHistologically confirmed Large B-cell lymphoma (LBCL) by WHO 2008 including:\n\ni. DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR ii. primary mediastinal (thymic) large B cell lymphoma; OR iii. transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma to DLBCL; OR iv. Follicular Lymphoma Grade 3B\n\n• Subjects with DLBCL, Follicular Lymphoma Grade 3B -or-\n\nSubjects with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation:\n\n1\\) Must have received an anthracycline regimen and an anti CD20 monoclonal antibody (unless documented CD20-negative) and be refractory or relapsed after second line of LBCL treatment. Subjects with a partial response to second line therapy must be ineligible for autologous transplant.\n\n* Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:\n\n  1. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL\n\n     Note: T cell\u002Fhistiocyte rich large B cell lymphoma is not eligible\n\n     The following criteria apply to all participants unless otherwise noted:\n\n  2\\. Measurable Disease:\n  1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\n     b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible\n  2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.\n  3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.\n\n  3\\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.\n\n  4\\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.\n\n  5\\. Meet required prior therapy washout windows prior to leukapheresis (see inclusion criteria for leukapheresis for details).\n\n  6\\. Participants with prior CAR therapy must be at least 30 days post CAR infusion and have \\\u003C 5% CD3+ cells express the previous CAR prior to apheresis, if a validated assay is available.\n\n  7\\. Toxicities from prior therapy stable or resolved (except for clinically non-significant toxicity and cytopenias covered in footnote).\n\n  8\\. Age ≥ 18 years of age. 9. Adequate performance status (ECOG 0, 1, or 2; or Karnofsky \\> 60%) 10. Adequate organ and marrow function as defined by:\n\n  \\- ANC ≥ 750\u002FuL\n  * Platelet count ≥ 50,000\u002FuL\n  * ALC ≥ 150\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \\\u003C 2 mg\u002FdL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg\u002Fdl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air ANC Platelet ALC Cr CreatCl AST\u002FALT Bilirubin LVEF O2 Sat\n  * 11\\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.\n\n    14\\. Must be able to provide informed consent (LAR is permitted if participant able to provide verbal assent).\n\nA participant will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n* Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n\n  2\\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety\n\n  3\\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.\n\n  4\\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and\u002For nucleic acid testing.\n\n  5\\. Active cerebrovascular ischemic\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.\n\n  6\\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.\n\n  7\\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n\n  8\\. Is pregnant or breastfeeding.\n\n  9\\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n\n  10\\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, or be likely to complete all protocol-required visits and procedures.",{"count":207,"type":21},148,[24],"This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed \u002F refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.",[186,188,29,211,212,189,185,213],"Lymphoplasmacytic Lymphoma","Burkitt Lymphoma","Large B-cell Lymphoma",[215,216,217,218,219,220],"lymphoma","leukemia","lymphodepleting chemotherapy","relapsed","refractory","systemic therapy","2025-08-04",{"date":223,"type":38},"2025-08-07",{"date":225,"type":38},"2024-03-29",{"date":227,"type":21},"2031-04",{"name":229,"class":98},"Stanford University",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":46},"100576147","assessment-of-disease-burden-in-hairy-cell-leukemia-100576147","NCT06781515","Assessment of Disease Burden in Hairy Cell Leukemia","BRAF","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of HCL patients:\n\n   1. newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or\n   2. in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or\n   3. in CR for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years).\n2. Age ≥ 18 years at enrollment\n3. Signature of written informed consent\n\nExclusion Criteria:\n\n1\\. Concomitant second malignancy.",{"count":238,"type":21},45,[240],"NA","Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients",[29],"2025-01-13",{"date":245,"type":38},"2025-01-17",{"date":247,"type":21},"2025-01",{"date":249,"type":21},"2025-11",{"name":251,"class":98},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100219266","phase-2-therapy-optimisation-for-the-treatment-of-hairy-cell-leukemia-100219266","NCT02131753","Therapy Optimisation for the Treatment of Hairy Cell Leukemia","Inclusion Criteria:\n\n* Patients with histologically verified hairy cell leukemia\n* Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and \u002F or co expression if cell surface antigens cluster of differentiation (CD) 19\u002FCD25 or CD19\u002FCD103 (b-ly7)\n* No previous cytostatic treatment (splenectomy or interferon treatment are allowed)\n* Need for treatment\n* Age at least 18 years old\n* General state of health according to WHO 0-2\n* Current histology, not older than 6 months\n* Written consent by patient\n\nExclusion Criteria:\n\n* Patients not fulfilling inclusion criteria above\n* Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and \u002F or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19\u002FCD103 without CD25\n* Pretreatment with purine analogues or other chemotherapeutics\n* Concomitant corticosteroid therapy\n* Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin \\> 2 mg\u002Fdl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase \\> 2 x upper limit of normal), the kidneys (creatinin \\> 2 mg\u002Fdl or creatinine clearance \\\u003C 50 ml\u002Fmin), central nervous system diseases including psychoses.\n* Proven HIV infection\n* Active Hepatitis\n* Other florid infections\n* Anamnesis \u002F diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)\n* Pregnant or lactating women","90 Years",{"count":260,"type":21},210,[57,262],"PHASE3","The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.\n\nThey have to be untreated so far or may be pretreated with alpha-interferon.",[29],[266,267,268],"hairy cell leukemia","untreated","cladribine subcutaneous","2024-08-20",{"date":271,"type":38},"2024-08-22",{"date":273,"type":4},"2004-05",{"date":275,"type":21},"2027-12",{"name":277,"class":98},"University of Giessen",76,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":288,"phases":4,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100505328","assessing-medical-trial-experiences-of-hairy-cell-leukemia-patients-100505328","NCT05859932","Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients","A Look at the Patterns in Clinical Research Participation Among Patients With Hairy Cell Leukemia","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.\n\nExclusion Criteria:\n\n* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study\n* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial\n* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.",{"count":287,"type":21},500,"OBSERVATIONAL","The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.\n\nThis research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for hairy cell leukemia.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of hairy cell leukemia studies.",[29],[266],"2023-05-05",{"date":294,"type":38},"2023-05-16",{"date":296,"type":21},"2024-06",{"date":298,"type":21},"2026-06",{"name":300,"class":45},"Power Life Sciences Inc."]