[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nhl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nhl":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,71,95,122,152,176,199,224],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100362726","phase-2-acalabrutinib-with-da-epoch-r-or-r-chop-for-people-with-untreated-diffuse-large-b-cell-lymphoma-100362726",false,"NCT04002947","Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","A Phase 2 Study of Acalabrutinib With DA-EPOCH-R or R-CHOP for Patients With Untreated Diffuse Large B-cell Lymphoma","-INCLUSION CRITERIA:\n\n1. Patients must have a confirmed histologic diagnosis of an aggressive B-cell lymphoma with morphologic appearance of DLBCL or high-grade B-cell lymphoma (HGBL) confirmed by the Laboratory of Pathology, NCI, with no prior treatment for DLBCL or HGBL. The following subtypes are included:\n\n   * DLBCL, NOS, Activated B-cell type (ABC)\n   * DLBCL, NOS, Germinal center B-cell type (GCB)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * Primary cutaneous DLBCL, leg-type\n   * EBV+ DLBCL, NOS\n   * DLBCL associated with chronic inflammation\n   * ALK+ large B-cell lymphoma\n   * High-grade B-cell lymphoma, NOS\n   * High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements\n\n   NOTE: Presence of concomitant indolent lymphomas such as follicular lymphoma, marginal zone lymphomas, monoclonal B-cell lymphocytosis or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma that are best categorized as composite or transformed lymphomas are allowed.\n2. A formalin-fixed tissue block or 15 slide of tumor sample (archival or fresh) must be available for performance of correlative studies.\n\n   NOTE: Tumor tissue may be from any previously collected tissue and adequacy is at the discretion of the Principal Investigator. Patients must be willing to have a tumor biopsy if adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n3. Measurable lymph nodes or masses of at least 1.5 centimeters (cm) on baseline CT or MRI\n4. Stage II, III, or IV disease as classified by the Ann Arbor Classification\n5. Age greater than or equal to 18 years\n6. ECOG performance status less than or equal to 2.\n7. Adequate organ and marrow function as defined below unless dysfunction is felt to be secondary to lymphoma involvement as determined by the treating investigator:\n\n   * absolute neutrophil count\\* \\>=1,000\u002FmcL\n   * hemoglobin\\* \\>= 8 g\u002FdL (transfusions permitted to meet criteria)\n   * Platelets \\>= 75,000\u002FmcL (transfusions not permitted)\n   * total bilirubin \\\u003C= 1.5 X institutional ULN (or \\\u003C= 3 X institutional ULN for patients with documented Gilberts syndrome or cholestatic obstruction or involvement by lymphoma)\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C= 3 X institutional ULN (\\\u003C= 5 x ULN for patients with cholestatic obstruction or involvement by lymphoma\n   * Serum creatinine \\\u003C= 2.0 mg\u002FdL\n\n   OR\n\n   -Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above 2 mg\u002FdL\n\n   \\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n   NOTE: In patients without bone marrow involvement, transfusions of RBCs are permitted to achieve the criterion hemoglobin of 8g\u002Fdl, but transfusions of platelets are not permitted to achieve the criterion platelet count of \\>75,000\u002FmcL. In patients with bone marrow involvement, all transfusions are permissible at the discretion of the investigator.\n8. Effects of acalabrutinib on the developing human fetus are unknown. For these reasons the following measures apply:\n\n   * Individuals of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n   * Individuals of childbearing potential who are sexually active must agree to highly effective contraception prior to study entry, for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later. Individuals who can father children must use highly effective contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of combined chemotherapy; there is no contraception timing requirement post-last dose of acalabrutinib alone if an individual who can father children does not initiate chemotherapy on study after the acalabrutinib window.\n   * Participants must not be planning to conceive or father children within the projected duration of the trial, starting with the pre-screening\u002Fscreening visit through 2 days after the last dose of acalabrutinib or 12 months after the last dose of combined chemotherapy, whichever is later.\n\n   NOTE: An individual is considered of childbearing potential, (i.e., fertile), following menarche and until becoming post-menopausal unless permanently sterile or have a congenital or acquired condition that prevents childbearing. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy at least 6 weeks before screening. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. In individuals of childbearing potential \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in individuals of childbearing potential not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient The investigator or a designated associate is requested to advise the subject how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence.\n\n   Individuals who can father children are considered to be of non-reproductive potential if they are permanently sterile due to bilateral orchiectomy.\n\n   Highly effective methods of contraception (to be used during heterosexual activity) are defined as methods that can achieve a failure rate of \\\u003C1% per year when used consistently and correctly. Such methods include:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable\n   * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n   * Bilateral tubal occlusion\n   * Vasectomy of participant or participant's partner (with medical assessment and confirmation of vasectomy surgical success)\n   * Sexual abstinence (only if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n\n   Hormonal contraception may be susceptible to interaction with study or other drugs, which may reduce the efficacy of the contraception method.\n\n   Abstinence (relative to heterosexual activity) can only be used as the sole method of contraception if it is consistently employed during the entire period of risk associated with the study treatments.\n\n   Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n9. Ability of patient to understand and the willingness to sign a written informed consent document.\n10. Any HIV status will be included in this study; status must be confirmed prior to enrollment.\n\nEXCLUSION CRITERIA:\n\n1. Patients who meet histologic criteria for the following subtypes are excluded:\n\n   * Primary DLBCL of the central nervous system (PCNSL)\n   * Primary mediastinal B-cell lymphoma (PMBL)\n   * Plasmablastic lymphoma\n   * Intravascular large B-cell lymphoma\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n2. Patients who, at the discretion of the investigator, need immediate cytoreductive chemotherapy such as patients with evidence of spontaneous tumor lysis or impending organ compromise are not eligible.\n3. Current or prior anti-cancer treatment for DLBCL prior to enrollment. Short course of corticosteroids (\\\u003C7 days) for acute issues prior to study enrollment are permitted.\n4. Major surgical procedure within 30 days of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n5. Requires treatment with moderate or strong CYP3A inhibitors or inducers\n6. Known lymphomatous involvement of the CNS\n7. Pregnant individuals, or individuals who intend to become pregnant during the study are excluded from this study because of potential teratogenic effects associated with acalabrutinib, R-CHOP, and\u002For DA-EPOCH-R\n8. The potential for all study treatments to be excreted in the milk of nursing mothers is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with acalabrutinib, nursing must be discontinued.\n9. Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n   -Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n\n   Uncontrolled active systemic infection\n   * Any condition that requires anticoagulation with warfarin or equivalent vitamin K antagonist\n   * Active bleeding, history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n   * Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)\n   * Active hepatitis C infection. NOTE: Subjects who are hepatitis C antibody positive will need to have a negative HCV PCR result before enrollment. Those with a positive PCR for hepatitis C are excluded.\n   * Active hepatitis B infection. NOTE: Patients who are hepatitis B surface antigen (HbsAg) positive will be excluded from enrollment. Patients who are hepatitis B core antibody (HbcAb) positive will need to have a negative HBV PCR result before enrollment. Those with a positive PCR for hepatitis B are excluded. Those who are hepatitis B core antibody (HbcAb) positive with a negative PCR for hepatitis B will be treated with antivirals designed to prevent hepatitis B reactivation (e.g., entecavir) throughout therapy and for 12 months after therapy and have monitoring for hepatitis B reactivation with PCR.\n   * History of hemorrhagic stroke or intracranial hemorrhage in preceding 6 months\n   * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled atrial fibrillation\u002Fflutter during screening are eligible.\n   * Uncontrolled autoimmune hemolytic anemia\n   * Inability to swallow oral medications, or disease involve that significantly limits absorption of oral medication\n   * Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n10. Concurrent participation in another therapeutic clinical trial.","ALL","18 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nDiffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma. Most people with this cancer can be cured. But those who are not cured have a poor prognosis. Researchers want to add another drug to standard treatment see if it can improve the cure rate.\n\nObjective:\n\nTo see if the drug acalabrutinib given with rituximab and standard combination chemotherapy can improve the cure rate of aggressive B-cell lymphomas such as diffuse large B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with an aggressive B-cell lymphomas that have not been treated\n\nDesign:\n\nParticipants will be screened with:\n\nBlood and urine tests\n\nPhysical exam\n\nMedical history\n\nTumor biopsy\n\nBone marrow biopsy: A needle will remove marrow from the participant s hipbone.\n\nLumbar puncture: If necessary, a needle will remove fluid from the participant s spinal canal.\n\nImaging scans\n\nParticipants will take the study drug for up to 14 days. It is a pill taken 2 times a day. Then they will have more scans. They will get rituximab and chemotherapy. They may get these drugs through a needle in an arm vein. Or they may them through a tube placed in a vein in their chest or in their neck. They might also keep taking the study drug. Each treatment cycle lasts 21 days. They will have up to 6 cycles.\n\nParticipants may have 4 doses of another drug injected into their spinal fluid.\n\nParticipants will have repeats of the screening tests throughout the study.\n\nParticipants will have a follow-up visit 30 days after their last treatment, then every 3 months for 2 years, then every 6 months for 3 years, and then yearly.",[26,27,28,29],"Non-Hodgkin's Lymphoma","Diffuse Large B-Cell Lymphoma","DLBCL","NHL",[31,32,33,34],"BTK Inhibitor","Calquence","ACP-196","Monoclonal Antibody","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2019-08-05",{"date":43,"type":20},"2031-03-31",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100614761","phase-1-a-study-to-assess-pk-safety-and-efficacy-of-hsk47977-tablets-in-subjects-with-relapsed-or-refractory-non-hodgkins-lymphoma-100614761","NCT07283796","A Study to Assess PK, Safety and Efficacy of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma","A Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK\u002FPD Characteristics of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form.\n2. Age ≥18 years, with no gender restriction.\n3. Pathologically confirmed patients with relapsed\u002Frefractory Non-Hodgkin Lymphoma (rrNHL).\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n5. Expected survival \\>3 months.\n6. Presence of measurable lesions.\n7. Adequate organ function.\n8. Agreement to undergo pathological tissue biopsy.\n9. Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.\n10. No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Concurrent presence of other severe, unstable diseases\u002Fconditions that, in the investigator's judgment, make participation in this study unsuitable.\n2. History of or current severe cardiovascular disease.\n3. Poorly controlled blood pressure during the screening period.\n4. Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.\n5. Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.\n6. History of allergies to the investigational drug or its excipients.\n7. Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration.\n8. Any other conditions that may increase subject risk or interfere with the trial results.\n9. Any other situations where the investigator deems the subject unsuitable for participation.",{"count":56,"type":20},110,[58],"PHASE1","This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK\u002FPD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.",[29],"2025-12-15",{"date":63,"type":39},"2025-12-19",{"date":65,"type":39},"2025-08-28",{"date":67,"type":20},"2027-12",{"name":69,"class":70},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100545716","phase-1-a-clinical-trial-in-adults-with-non-hodgkin-lymphoma-nhl-with-a-particular-emphasis-on-cutaneous-t-cell-lymphoma-ctcl-testing-the-safety-and-activity-of-a-novel-drug-to-inhibit-a-protein-called-tumor-necrosis-factor-receptor-2-that-drives-both-lymphoma-growth-and-escape-of-the-immune-system-100545716","NCT06385522","A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System","A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma","Key Inclusion Criteria:\n\n* Histologically confirmed relapsed or refractory B cell NHL (DLBCL, MCL, MZL), PTCL or CTCL (MF or SS subtype) as per 2017 World Health Organization classification after at least 2 prior lines of systemic therapy and have received, or are not eligible for, approved or available treatments expected to provide benefit. CTCL patients should be Stage ≥1B through 4 and Stage 1A (see Appendix 1) with plaque disease without treatment options, in which case the patient should be discussed with the sponsor after submitting documentation of disease stage and treatment history. Patients with indolent lymphoid malignancies (CTCL, MZL) must need new treatment regimen in the opinion of the treating Investigator.\n* Age ≥18 years.\n* Life expectancy ≥3 months.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nKey Exclusion Criteria:\n\n* Patients with prior exposure (up to 12 months) to PD-1\u002FPD-L1 therapies.\n* Known hypersensitivity to any excipients that are used in the BITR2101 formulation as noted in Investigator Brochure.\n* Autoimmune diseases that have been sufficiently active to require medications in the 3 months before screening, except autoimmune endocrinopathies, such as hypothyroidism, that are stable with hormone-replacement therapy. Including inflammatory diseases such as arthritis, colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease (COPD). The SRC may allow patients with well controlled arthritis or COPD in the expansion cohort if there is no indication of inflammatory disease flare and no blood cytokine evidence of a systemic inflammatory response in the 3 months prior to enrollment.\n* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with participating in the protocol.\n* History or evidence of clinically significant cardiovascular disease.\n* Severe dyspnea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study for the duration of this study or the FU period of an interventional study.\n* Prior or current anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy within 4 weeks of the first BITR2101 administration.\n* Continuous corticosteroid use exceeding 10 mg\u002Fday prednisone or equivalent.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply",{"count":79,"type":20},37,[58],"The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year.",[29,83,84],"Cutaneous T Cell Lymphoma","Peripheral T-cell Lymphoma","NOT_YET_RECRUITING","2025-07-04",{"date":88,"type":39},"2025-07-08",{"date":90,"type":20},"2025-08",{"date":92,"type":20},"2027-02",{"name":94,"class":70},"Boston Immune Technologies and Therapeutics",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":47},"100342505","phase-2-a-randomized-phase-ii-study-of-hyperbaric-oxygen-in-improving-engraftment-in-umbilical-cord-blood-stem-cell-transplant-100342505","NCT03739502","A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant","A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation","HBO-UBC","Inclusion Criteria:\n\n* Voluntary written informed consent\n* Patients who are considered for allogeneic transplantation based on their disease risk (see below) but lack matched sibling or unrelated donors or who are unable to proceed to allogeneic transplant within 8 weeks, will be considered for UCB transplantation on this study. Only patients for whom RIC will be considered are eligible. RIC is considered in those older than 45 or younger than 45 with Hematopoietic Cell Transplant (HCT) Comorbidity Index of 3 or higher (HCT) Comorbidity Index can be calculated using the following link: http:\u002F\u002Fwww.hctci.org\u002FHome\u002FCalculator\n* Patients with acute myeloid leukemia (AML) in CR1 that is not considered favorable-risk (favorable risk is defined as patients with t(15;17)(q22;q21), t(8;21)(q22;q22), inv(16)(p13q22)\u002Ft(16;16)(p13;q22), NPM1 mutation without FLT3-ITD, and double-mutated CEBPA58,59), AML in CR2 or subsequent CR, high-risk acute lymphoblastic leukemia (ALL) in CR1, or ALL in CR2 or higher, biphenotypic leukemia defined as coexpression of B-lymphoid and myeloid markers or T-lymphoid and myeloid markers in the blast population60or undifferentiated leukemia in ≥CR1. Myelodysplatic syndrome (MDS)\u002Fmyeloproliferative neoplasm (MPN) patients with less than 10% bone marrow blasts and no peripheral blood blasts on pre-transplant bone marrow aspirate\u002Fbiopsy are considered for FluCyTTBI regimen. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification61) Hodgkin's disease (HD) that relapsed following high-dose therapy. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification) non-Hodgkin's lymphoma (NHL) patients who relapsed post-high-dose therapy and autologous transplantation. Subjects should be enrolled within 30 days of transplant.\n* For ALL, high-risk features are defined using modified Hoelzer risk criteria62, these criteria are:\n\n  1. High white blood cell count at diagnosis (ie, \\>30,000\u002FmicroL in B-ALL or \\>100,000\u002FmicroL in T-ALL).\n  2. Clonal cytogenetic abnormalities - t(4;11), t(1;19), t(9;22), or BCR-ABL gene positivity.\n  3. Progenitor-B cell immunophenotype (eg, blasts expressing membrane CD19, CD79a, and cytoplasmic CD22).\n  4. Length of time from start of induction therapy to attainment of CR greater than four weeks.\n  5. Older age - \\>60 years old is high risk, 30 to 59 years old is intermediate risk.\n  6. MRD - a post-remission bone marrow MRD level ≥10-3 by molecular tests.\n* Subjects must be ≥ 18 years old and ≤ 70 years old\n* Karnofsky performance status (KPS) of ≥ 70% (Appendix A).\n* Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:\n\n  * ALT, AST: \\\u003C 4x IULN\n  * Total bilirubin: ≤ 2.0 mg\u002FdL\n  * Creatinine: ≤ 1.5 x ULN\n  * EF measured by 2D-ECHO or MUGA scan of ≥ 45%\n  * FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin).\n  * EKG with no clinically significant arrhythmia.\n* Patients should have New York Heart Association (NYHA) Functional Classification, class -1 (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina pain) or class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain).\n* Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.\n* Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n  1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n  2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Severe chronic obstructive pulmonary disease requiring oxygen supplementation\n* History of spontaneous pneumothorax\n* Active ear\u002Fsinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, throat provider.\n* Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.\n* Prior chest surgery requiring thoracotomy or direct chest irradiation.\n* Recent of sinus or ear surgery, excluding myringotomy or ear tubes (within the last 5 years).\n* Claustrophobia\n* Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen.\n* History of seizures\n* No active tobacco use 72 hours prior to transplant until complete transplant recovery.","70 Years",{"count":105,"type":20},64,[23],"The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).",[109,29,110,111,112],"AML","Hodgkin Disease","All","Myelodysplastic Syndrome","2025-07-02",{"date":88,"type":39},{"date":116,"type":39},"2019-02-28",{"date":118,"type":20},"2027-06",{"name":120,"class":121},"University of Rochester","OTHER",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":140,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100525280","phase-1-idp-023-as-a-single-agent-and-in-combination-with-antibody-therapies-in-patients-with-advanced-hematologic-cancers-100525280","NCT06119685","IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers","Phase 1\u002F2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers","Key Inclusion Criteria:\n\n* For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and\u002For refractory (R\u002FR) disease after ≥ 3 prior lines of therapy.\n* For NHL patients: R\u002FR disease and failed ≥ 2 lines of systemic chemotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy of greater than 12 weeks per the Investigator.\n\nKey Exclusion Criteria:\n\n* Impaired cardiac function or history of clinical significant cardiac disease.\n* Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.\n* Active SARS-CoV-2 infection.\n* Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.",{"count":130,"type":20},128,[58,23],"This is an open label, Phase 1\u002F2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.",[29,134,135,136,137,138,139],"Multiple Myeloma","Blood Cancer","Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Multiple Myeloma","Relapsed Multiple Myeloma",[141],"Advanced Hematologic Cancers","2025-05-30",{"date":144,"type":39},"2025-06-03",{"date":146,"type":39},"2023-10-25",{"date":148,"type":20},"2029-12-31",{"name":150,"class":70},"Indapta Therapeutics, INC.",12,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":47},"100572317","phase-1-a-phase-1-study-of-fd-001-in-recurrent-refractory-rramlnhlmmmds-100572317","NCT06731699","A Phase 1 Study of FD-001 in Recurrent \u002FRefractory (R\u002FR)AML\u002FNHL\u002FMM\u002FMDS","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of FD-001 in Patients with Relapsed or Refractory Hematological Malignancies.","Inclusion Criteria:\n\n1. Willing to voluntarily participate in this clinical study; possess a comprehensive understanding of, provide consent for, and sign the written informed consent form (ICF) for this study; demonstrate willingness to adhere to and complete all study procedures.\n2. Age range from 18 to 80 years (inclusive), with no gender restrictions.\n3. ECOG performance status ≤2 (refer to Appendix 1).\n4. Expected minimum survival period of at least 3 months.\n5. Patients diagnosed with hematological malignancies confirmed through pathological and\u002For cytological examinations, who have either failed or not received standard treatment due to lack of efficacy or intolerance. This includes patients with recurrent\u002Frefractory conditions.\n6. Presence of at least one measurable lesion:\n\n   * For AML: bone marrow containing more than 5% primitive\u002Fimmature cells (excluding regeneration after consolidation chemotherapy).\n   * For MDS: bone marrow aspirate or biopsy pathological examination revealing less than 20% primitive cells.\n   * For MM: meeting any of the following criteria:\n\n     1. Monoclonal protein detected in blood ≥1 g\u002FdL (10g\u002FL) through serum protein electrophoresis.\n     2. Urine monoclonal protein ≥200 mg over a span of 24 hours.\n     3. If monoclonal protein is undetectable in blood or urine, affected-to-unaffected serum FLC ratio should be ≥100 (with affected serum FLC level being ≥100 mg\u002FL).\n   * For NHL: presence of measurable lesions identified by CT, PET-CT, or PET-MRI scans such as lymph node lesions with major axis \\>1.5 cm or extranodal lesions with major axis \\>1.0 cm); CLL\u002FSLL: peripheral blood monoclonal lymphocytes ≥5.0×10\\^9\u002FL; WM: IgM \\>2×ULN.\n7. Adverse effects resulting from previous anti-cancer therapy should have recovered to grade ≤1 (continuous hair loss excluded along with laboratory tests specified in criterion 8).\n8. With sufficient organ function support, all the following criteria must be met during the laboratory tests in the screening period:\n\n   * The white blood cell (WBC) count should be less than or equal to 30×10\\^9\u002FL before the first use of the investigational drug; (This criterion is only applicable to AML and MDS, and the use of hydroxyurea to lower the white blood cell count is permitted.) The absolute neutrophil count (ANC) should be greater than or equal to 1.0×10\\^9\u002FL before the first use of the investigational drug, and it can be relaxed to 0.75×10\\^9\u002FL in the case of bone marrow infiltration; the platelet count (PLT) should be greater than or equal to 70×10\\^9\u002FL before the first use of the investigational drug, and it can be relaxed to 50×10\\^9\u002FL in the case of bone marrow infiltration; the hemoglobin (HB) level should be greater than or equal to 70 g\u002FL before the first use of the investigational drug, and it can be relaxed to 60 g\u002FL in the case of bone marrow infiltration (This criterion is only applicable to MM and NHL; It is required that this test was not conducted within 7 days before blood collection after the administration of G-CSF (or GM-CSF), erythropoietin, thrombopoietin treatment or component blood transfusion)\n\nExclusion Criteria:\n\n1. Within 4 weeks prior to the first dose of the study drug or within 5 half-lives (whichever is shorter), the subject has received anti-cancer therapy, including chemotherapy, immunotherapy, targeted therapy (excluding hydroxyurea therapy and prophylactic intrathecal injection of chemotherapy drugs); received radiation therapy within 2 weeks; received anti-cancer therapy with Chinese herbal medicine within 2 weeks;\n2. Chronic myeloid leukemia (CML) with BCR\u002FABL positivity;\n3. The subject has central nervous system malignant tumor infiltration;\n4. The subject has another malignant tumor at the same time (excluding IB stage or lower-stage cervical cancer that has been cured, non-invasive basal cell or squamous cell skin cancer, and other malignant tumors that have achieved complete remission (CR) \\>10 years and \\>5 years, respectively);\n5. Within 4 weeks prior to the first dose of the study drug, the subject has received an active or attenuated live vaccine;\n6. The subject has a history of clear alcohol and drug abuse; a history of severe allergies in the past, or is allergic to any component of the study drug.","80 Years",{"count":161,"type":20},72,[58],"This is a single-arm, open-label, dose-escalation and dose-expansion phase I clinical trial aimed at assessing the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic profile, and preliminary efficacy of FD-001 capsules in the treatment of recurrent\u002Frefractory hematologic malignancies(AML\u002FMDS\u002FNHL\u002FMM). The trial consists of two phases: the initial phase (dose escalation) and the subsequent phase (dose expansion). The primary objectives are to evaluate the safety and tolerability of FD-001 in subjects with recurrent\u002Frefractory hematologic tumors and determine the maximum tolerated dose (MTD) as well as the recommended Phase II dose (RP2D) for FD-001 in this patient population.",[109,29],[166,109,29],"FD-001","2024-12-12",{"date":169,"type":39},"2024-12-17",{"date":171,"type":39},"2024-03-11",{"date":173,"type":20},"2026-03-01",{"name":175,"class":70},"Chengdu FenDi Pharmaceutical Co., Ltd.",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":198},"100488539","phase-2-comparison-of-point-of-care-produced-car-t-cell-with-commercial-car-t-cells-in-patients-with-rr-lbcl-100488539","NCT05641428","Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R\u002FR LBCL","A Phase II Non-inferiority Study Comparing Point-of-care Produced CAR T-cell to Commercial CAR T-cells in Patients with Relapsed\u002Frefractory Non-Hodgkin Lymphoma","HOVON161","Inclusion Criteria:\n\n* Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements with DLBCL histology (DHL\u002FTHL) and FL3B, T-cell\u002Fhistocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, transformed lymphoma (transformed follicular) and R\u002FR after at least 2 lines of systemic therapy\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG)\u002FWHO performance status 0-2\n* Secondary central nervous system (CNS) involvement is allowed however, then he\u002Fshe must have\n\n  \\* No signs or symptoms of CNS involvement that would hamper adequate ICANS assessment\n* Estimated life expectancy of \\>3 months other than primary disease\n* Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n* Signed and dated informed consent before conduct of any trial-specific procedure\n* Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\<1.0x10\\^9\u002FL\n* Platelet count \\<50x10\\^9\u002FL\n* Absolute lymphocyte count \\<0.1x10\\^9\u002FL\n* Primary CNS lymphoma\n* Known history of infection with hepatitis C or B virus unless treated and confirmed to be polymerase chain reaction (PCR) negative\n* Active HIV infection with detectable viral load or CD4 T-cell count below 0.20x10\\^9\u002FL\n* Known history or presence of seizure activities or on active anti- seizure medications within the previous 12 months\n* Known history of CVA within prior 12 months\n* Unstable neurological deficits\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease\n* Active systemic autoimmune disease for which immunosupressive therapy is required\n* Presence of CNS disease that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity, baseline dementia that would interfere with therapy or monitoring, determined using mini-mental status exam at baseline\n* Active systemic fungal, viral or bacterial infection\n* Clinical heart failure with New York Heart Association class ≥2 (appendix F) or Left Ventricular Ejection Fraction (LVEF) \\<40%\n* Resting oxygen saturation \\<92% on room air\n* Liver dysfunction as indicated by total bilirubin, AST and\u002For ALT \\>5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease\n* GFR \\<40 mL\u002Fmin calculated according to the modified formula of Cockcroft and Gault or by direct urine collection\n* Pregnant or breast-feeding woman\n* Active other malignancy requiring treatment\n* Medical condition requiring prolonged use of systemic immunosuppressives with exception of prednisolone \\<10 mg\u002Fday\n* History of severe immediate hypersensitivity reaction against any drug or its Ingredients\u002Fimpurities that is scheduled to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication\u002Fsalvage therapies for treatment related toxicities\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule",{"count":185,"type":20},300,[23],"A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R\u002FR) DLBCL.",[29,189],"DLBCL - Diffuse Large B Cell Lymphoma","2024-09-19",{"date":192,"type":39},"2024-09-23",{"date":194,"type":39},"2022-10-18",{"date":67,"type":20},{"name":197,"class":121},"University Medical Center Groningen",7,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":4},"100553457","phase-2-cmopr-in-the-treatment-of-untreated-non-hodgkins-lymphoma-100553457","NCT06486337","CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma","A Single-arm, Multi-center, Prospective Clinical Study of Mitoxantrone Hydrochloride Liposome Injection-based CMOP±R Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);\n* Age: 18-75 years old;\n* Expected survival time ≥ 3 months;\n* Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;\n* Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \\>1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \\>1.0cm;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.\n* Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, Platelet count (PLT) ≥75×10\\^9\u002FL, Hemoglobin(HB)≥ 80 g\u002FL(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL, Platelet count (PLT) ≥50×10\\^9\u002FL, Hemoglobin(HB)≥ 75g\u002FL);\n* Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);\n\nExclusion Criteria:\n\n* Subjects have previously received anthracyclic drug pretreatment;\n* Hypersensitivity to any study drug or its components;\n* Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);\n* Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval \\>480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.\n* Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\\^3 copies\u002FmL of hepatitis B virus DNA; more than 1x10\\^3 copies\u002FmL of hepatitis C virus RNA);\n* Human immunodeficiency virus (HIV) infection (positive HIV antibody);\n* Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast\u002Fcervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);\n* Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;\n* Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;\n* Other researchers judge not to Eligibility to participate in this study.","75 Years",{"count":208,"type":20},197,[23],"This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.",[29],[213,214],"newly diagnosed non-Hodgkin's lymphoma","Mitoxantrone hydrochloride liposome","2024-06-30",{"date":217,"type":39},"2024-07-03",{"date":219,"type":20},"2024-07-10",{"date":221,"type":20},"2027-08-31",{"name":223,"class":121},"The First Affiliated Hospital of Soochow University",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":47},"100396310","phase-1-assessment-of-safety-and-efficacy-of-im19-for-recurrent-or-refractory-rr-non-hodgkins-lymphomanhl-patients-100396310","NCT04440436","Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R\u002FR) Non-Hodgkin's Lymphoma(NHL) Patients","Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R\u002FR) CD19 Positive Aggressive Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.\n* CD20 positive patients undergo corresponding targeted therapy.\n* Patients must have evaluable evidence of disease (according to Lugano 2014 standards).\n* ≥ 18 years old.\n* The expected survival period is more than 3 months.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up\n* Participate voluntarily in this experiment and sign the informed consent.\n\nExclusion Criteria:\n\n* The investigators judged patients with gastrointestinal lymph nodes and\u002For central nervous system involvement who may be at risk for CAR-T treatment.\n* Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease\n* Subject has used chemotherapy or radiotherapy within three days before the blood collection period.\n* Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).\n* Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection\n* Subject has used any gene therapy products before.\n* Subject with a history of epilepsy or other central nervous system diseases.\n* Active Hepatitis B Virus or Hepatitis C Virus infections\n* The subject with other tumors in the past 5 years.\n* Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.",{"count":232,"type":20},52,[58,23],"This is a phase I\u002FII, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R\u002FR Non-Hodgkins Lymphoma in China.",[29],"2020-12-04",{"date":238,"type":39},"2020-12-08",{"date":240,"type":39},"2020-06-04",{"date":242,"type":20},"2035-06-04",{"name":244,"class":70},"Beijing Immunochina Medical Science & Technology Co., Ltd."]