[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"phase-2-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:phase-2-study":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100614754","phase-2-a-phase-ii-study-evaluating-bms-986504-in-mtap-deleted-pancreatic-cancer-100614754",false,"NCT07283705","A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer","Eligibility Criteria\n\n* Age ≥18 years.\n* Homozygous MTAP deletion detected by NGS. Test can be performed on an archival tissue collected within 6 months from study enrollment and on blood samples.\n* ECOG performance status 0-1.\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)\n* Adequate organ and marrow function as defined below\n\n  * Hemoglobin ≥9.0 g\u002FdL with no packed red blood cell transfusions in the past 7 days.\n  * Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL.\n  * Platelet count ≥100 x 10⁹\u002FL with no platelet transfusions in the past 7 days.\n  * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n  * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional ULN value unless liver metastases are present, in which case ≤5 x ULN.\n* Calculated creatinine clearance ≥50 mL\u002Fmin (using Cockroft-Gault formula or 24-hour urine collection).\n* Participants are allowed to have received 1 month of GA (cohort 1 and 2) and mFolfirinox (cohort 3) in consideration of the aggressive nature of PDAC and the time required for to test MTAP-deficiency\n* Agree to follow the study protocol, including treatment, scheduled visits, and examinations, for the duration of the study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\n  1 Female (as assigned at birth) participants\n* Women of child-bearing potential (WOCBP) include all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114): :\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* WOCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year) during the intervention period and for at least 9 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n\n  * WOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception.\n  * WOCBP participants must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, and Implantable or injectable contraceptives. . Not engaging in sexual activity for the entire period of risk associated with the study intervention is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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\n    2 Male (as assigned at birth) participants\n* Male (as assigned at birth) participants will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n* Male (as assigned at birth) participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 6 months after the last dose of study intervention or according to approved local product label requirements for individual chemotherapy agents, whichever is longer.\n* Male (as assigned at birth) participants must refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer. Participants should be advised to seek advice about sperm donation and cryopreservation of germ cells before treatment.\n* WOCBP partners of male (as assigned at birth) participants should be advised to use a highly effective method of contraception during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for individual chemotherapy agents, whichever is longer, for the male participant.\n\nCohort 1 specific criteria:\n\n* Resectable or borderline resectable pancreatic adenocarcinoma per NCCN version 3.202432 that have not received any neoadjuvant treatment\n\n  o Resectable PDAC will be defined as the tumor with:\n* No arterial tumor contact (celiac axis \\[CA\\], superior mesenteric artery \\[SMA\\], or common hepatic artery \\[CHA\\])\n* No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity.\n* Borderline PDAC will be defined as the tumor with:\n\n  o For tumors of the pancreatic head\u002Funcinate process:\n* Solid tumor contact with CHA without extension to CA or hepatic artery bifurcation, allowing for safe and complete resection and reconstruction.\n* Solid tumor contact with the SMA of ≤180°.\n* Solid tumor contact with variant arterial anatomy (eg, accessory right hepatic artery, replaced right hepatic artery, replaced CHA, and the origin of replaced or accessory artery) and the presence and degree of tumor contact should be noted if present, as it may affect surgical planning.\n* Solid tumor contact with the SMV or PV of \\>180°, contact of ≤180° with contour irregularity of the vein or thrombosis of the vein but with suitable vessel proximal and distal to the site of involvement, allowing for safe and complete resection and vein reconstruction.\n* Solid tumor contact with the inferior vena cava (IVC).\n\n  o For tumors of the pancreatic body\u002Ftail:\n* Solid tumor contact with the CA of ≤180°\n\nCohort 2 specific criteria:\n\n* Locally advanced, unresectable pancreatic cancer per NCCN version 3.202432\n\n  o For tumors of the head\u002Funcinate process:\n* Solid tumor contact \\>180° with the SMA or CA\n* Unreconstructible SMV\u002FPV due to tumor involvement or occlusion (can be due to tumor or bland thrombus).\n\n  o For tumors of the pancreatic body\u002Ftail:\n* Solid tumor contact of \\>180° with the SMA or CA.\n* Solid tumor contact with the CA and aortic involvement.\n* No prior treatment with the exception of one month of chemotherapy with GA without progression of disease\n\nCohort 3 specific criteria:\n\n* Metastatic pancreatic adenocarcinoma.\n* No prior treatment, except one month of chemotherapy with mFOLFIRINOX without progression of disease.\n\nExclusion Criteria\n\n* Prior treatment with PRMT5 and MAT2A inhibitors.\n* Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to trial enrolment is not permitted.\n* Participants with other primary cancers are excluded, except for adequately treated nonmelanoma skin cancer, prostate cancer post-resection with undetectable PSA, in-situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or solid tumors (including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study entry.\n* Major surgery within 2 weeks of starting treatment is not permitted. Participants must have recovered from the effects of any major surgery.\n* Significant third-space fluid retention (e.g., ascites or peritoneal effusion) that requires drainage within 1 month prior to randomization.\n* Cardiac abnormalities including:\n\n  * Left ventricular ejection fraction \\\u003C 50%\n  * History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \\> 480 msec, except for right bundle branch block\n  * Uncontrolled\u002Fsymptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following:\n* Cardiac angioplasty or stenting, myocardial infarction, stroke\u002Ftransient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, myocarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade's de pointes)\n* Ongoing need for a medication with a known risk of Torsade's de Pointes or known as a strong inhibitor or strong inducer of CYP3A4 and\u002For P-glycoprotein or a proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry. The following drug interaction databases and other literature can be utilized to determine the CYP3A4\u002FPgp inhibitors and inducers:\n\n  * https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-anddruginteractions- table-substrates-inhibitors-and-inducers.\n  * https:\u002F\u002Fdruginteractions.medicine.iu.edu\u002FMainTable.aspx. Note: Please consult with the Sponsor Medical Monitor for any uncertainties regarding potential CYP3A4 and P-gp modulators.\n* Active viral hepatitis, including the following:\n\n  * Any positive test result for hepatitis B virus (HBV) indicating presence of virus, e.g., HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior vaccination or resolved infection are eligible to enroll.\n  * Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV RNA).\n  * Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.\n* Known human immunodeficiency virus (HIV) positive with an AIDS-defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FμL. Participants with HIV are eligible if they have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization and continue on ART as clinically indicated while enrolled on study. Viral serology only to be conducted if locally mandated and, if done, must be performed within 28 days of randomization.\n* Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to the first dose of study intervention.\n* Live\u002Fattenuated vaccine received within 30 days of first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.\n* Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study.\n* Prior organ allograft.\n* History of allergy to study intervention or any of its components.\n* Known central nervous system (CNS) metastases or leptomeningeal disease is exclusionary unless adequately treated and the participant is no longer on steroids or anticonvulsants.\n* Participants unable to swallow oral medication or with gastrointestinal disorders that, per the treating physician's judgement, would likely to interfere with drug absorption, are excluded.\n* Pregnant or breastfeeding women are excluded.\n* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or multiple allergies.\n\nCohort 1 specific criteria:\n\n* Radiographically detectable metastatic disease and\u002For locally advanced PDAC.\n* Anticipated need for preoperative radiation therapy (as determined per the treating medical team: medical oncologist and\u002For surgical oncologist at the time of study enrollment)\n\nCohort 2 specific criteria:\n\n* Radiographically detectable metastatic disease.\n* Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.\n* Participants with more than one prior line of therapy are excluded.\n* Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed.\n\nCohort 3 specific criteria:\n\n* Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.\n* Participants with more than one prior line of therapy are excluded.\n* Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed","ALL","18 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To find out if the combination of BMS-986504 plus neoadjuvant\u002Fadjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer.",[25,26,27],"Phase 2 Study","BMS-986504","MTAP-deleted Pancreatic Cancer","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-08","ACTUAL",{"date":34,"type":19},"2026-05-18",{"date":36,"type":19},"2031-10-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100612705","phase-2-phase-2-study-of-btki-rituximab-induction-followed-by-glofitamab-consolidation-in-high-risk-untreated-mcl-patients---window-4-study-100612705","NCT07257055","Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study","Eligibility Criteria\n\nParticipants must meet the following criteria for study entry:\n\n1. Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of chromosome translocation t (11;14), (q13;q32) and\u002For overexpression of cyclin D1 in tissue biopsy. Cyclin D negative MCL are allowed after discussion with study PI.\n2. Participants should have a life expectancy \\>= 12 weeks.\n3. Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab therapy.\n4. High risk MCL (Blastoid\u002Fpleomorphic histology, high Ki-67 (≥50%), TP53\u002FNOTCH1\u002F2, NSD2, UBR5, TRAF2, SP140, SMARCA4, KMT2D, BIRC3 mutated or any of these mutations or more than 2 mutations with some evidence of prognostic impact, complex karyotype and\u002For Bulky nodal disease \\>= 5 cm or spleen \\>= 20 cm, FISH positive for TP53 or MYC from involved tissues or TP53 and MYC positive intensity in lymphoma cells in involved tissues (positive by hem-path criteria at MDACC), high risk MIPI score (with\u002Fwithout Ki-67%). Presence of any or all of these features would qualify as high risk but will need to be reviewed and approved by the study PI.\n\n6\\. Participants who are willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.\n\n7\\. Understand and voluntarily sign an IRB-approved informed consent form. 8. Age ≥ 18 years at the time of signing the informed consent. 9. Bi-dimensional measurable disease using the 2014 Cheson criteria (Measurable disease by PETCT scan or CT scan (if PET-CT not approved and study PI approves) defined as at least 1 lesion that measures ≥ 1.5 cm in single dimension.) and\u002For spleen only involved (\\>=20 cm). Leukemic phase MCL are allowed without bulky measurable disease if they have other high-risk features after discussion with the study PI. These participants are allowed if they meet any other high-risk features, determined by the study PI.\n\n10\\. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. 11. Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, antihypertensive, prior ablation, anti-arrhythmia, prior arrhythmias, baseline EKG abnormalities and cardiology clearance are allowed. Ejection fraction \\>=50% and cardiology evaluation is needed. (Echo and EKG and cardiology consultation within 2 months prior to C1D1 are allowed).\n\n12\\. An absolute neutrophil count (ANC) \\> 1,000\u002Fmm3 and platelet count \\>100,000\u002Fmm3 (Participants who have \\>50% bone marrow or spleen infiltration by MCL are eligible if their ANC is ≥ 500\u002Fmm3 \\[growth factor allowed\\] or their platelet level is equal to or \\>= than 30,000\u002Fmm3 (transfusions allowed) These participants should be discussed with the PI of the study for final approval). Hemoglobin \\> 8.0 g\u002FdL (\\> 80 g\u002FL), unsupported for 2 days before first treatment (unless attributable to the underlying disease as determined by the study PI) 13. Serum bilirubin \\\u003C1.5 mg\u002Fdl, AST (SGOT) and ALT (SGPT) \\\u003C 2.5 x upper limit of normal or \\\u003C 5 x upper limit of normal if hepatic metastases are present. Gilbert's disease is allowed.\n\n14\\. Creatinine clearance. \\>=30 mL\u002Fmin (by 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation or 2021 CKD-EPI creatinine-cystatin C equation., APPENDIX VI I) 15. Contraception in female participants of childbearing potential- female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab and 2 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period.\n\n16\\. A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (³ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\n17\\. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation in female of child-bearing potential, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n18\\. Hormonal contraceptive methods are also recommended to be supplemented by a barrier method.\n\n19\\. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\n20\\. Contraception for male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below: 21. With a female partner of childbearing potential or pregnant female partners, male participants 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 6 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period.\n\n22\\. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. ..\n\na. Females must agree to abstain from breastfeeding during study participation and for at least 12 months after glofitamab discontinuation. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. WOCBP and males must be willing to use highly effective methods of birth control. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and 1 week after the last dose of acalabrutinib b. Females of childbearing potential (FCBP§ ) must: i. Have one negative pregnancy tests via serum in some cases urine (as clinically indicated) one week or immediately prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, prior to day 1 of each cycle, and after end of study therapy. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n\nii. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice. Otherwise, she must agree to use, and be able to comply with highly effective contraception.\n\nc. Male subjects must: i. A male subject who is sexually active with a female with reproductive potential is also recommended to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F suppository (including dose interruptions), even if they have undergone a successful vasectomy, from the time of signing consent and for at least 2 months after the last dose of glofitamab, 6 months after treatment with obinutuzumab, or 2 months after the last dose of tocilizumab (if applicable), whichever is longer. For male participants with a pregnant or non-pregnant WOCBP partner, should use barrier contraception, during treatment and for 1 week after the last dose of acalabrutinib, 180 days following the last dose of rituximab, 2 months following the last dose of glofitamab,6 months following the last dose of obinutuzumab, 2 months following the last dose of tocilizumab (if applicable), , whichever is longer, even if they have had a successful vasectomy.) d. Participant must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab. e. f. Have achieved complete metabolic response by Lugano criteria\\[35\\] to go to part 2 for glofitamab consolidation g. Performance status ≤1 on the ECOG scale h. All subjects must i. Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.\n\nExclusion Criteria Having radiologically confirmed relapsed\u002Frefractory disease.\n\n1. Isolated bone marrow or GI only disease MCL participants and\u002For lack of any measurable disease, except if participants have leukemic phase MCL with any high risk features.\n2. Pregnant or breast-feeding females.\n3. Participants who are primary refractory to BTKi-R (No response\u002Fprogressive disease within first 3 months of BTKi-R)\n4. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.\n5. Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.\n6. Known HIV infection.\n7. Known history of hemophagocytic lymphohistiocytosis (HLH)\n8. Known or suspected chronic active Epstein-Barr virus infection (clearance with infectious disease is needed to allow these participants)\n9. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.\n10. Participants who do not meet high risk features as indicated above in inclusion.\n11. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded (unless cleared by hepatology and ID team after discussion with study PI). Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible. Those who are hepatitis C PCR positive will be excluded.\n12. Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ ca prostate, in situ melanoma (\\> 5 mm margins) or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to \\\u003C 3 years or not on active systemic chemotherapy.\n13. Central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML). Magnetic resonance imaging (MRI) of the brain, if performed, showing evidence of central nervous system (CNS) lymphoma or Lumbar puncture with flow cytometry, if performed, with CSF involvement.\n14. History or presence of uncontrolled CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement.\n15. Active bleeding, history of bleeding diathesis (such as Hemophilia or Von-Willebrand disease), Any history of intracranial bleed or stroke within 6 months of first dose of study drug.\n16. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).\n17. Malabsorption syndrome, disease which is clinically significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of BTKi. These participants may be allowed after discussion, clearance with GI team and discussion with the study PI.\n18. Presence of a clinically significant gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.\n19. Requires anticoagulation with warfarin or equivalent vitamin K antagonist, active treatment for pulmonary embolism (PE)\u002F deep vein thrombosis (DVT) and persons with mechanical cardiac valves. These participants may be allowed after review with benign hematology and study PI.\n20. Concomitant use of corticosteroids at \\> 20 mg prednisone or equivalent per day longer than 2 weeks.\n21. Primary immunodeficiency which is clinically active\n22. History of confirmed autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years. Rheumatology clearance and approval by study PI is required for pts with remote history of auto-immune disease.\n23. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited.\n24. Requires treatment with strong CYP3A inhibitors or inducers.\n25. 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 (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study and\u002For any of the following cardiac related conditions, unless cleared by cardiology and study PI:\n26. NYHA Class III and IV heart failure,\n27. Active\u002Fsymptomatic coronary artery disease,\n28. Myocardial infarction in the preceding 6 months,\n29. Significant conduction abnormalities, including but not limited to:\n30. Left bundle branch block,\n31. 2nd degree AV block type II,\n32. 3rd degree block,\n33. QT prolongation (QTc \\> 500 msec),\n34. Sick sinus syndrome,\n35. Ventricular tachycardia,\n36. Symptomatic bradycardia (heart rate \\\u003C 50 bpm),\n37. Persistent and uncontrolled atrial fibrillation.\n38. Uncontrolled hypertension\n39. Uncontrolled Hypotension\n40. Light headedness and syncope,\n41. Acute infection requiring systemic anti-infective treatment systemic antibiotics, antivirals, or antifungals, or including subjects with positive cytomegalovirus \\[CMV\\] DNA polymerase chain reaction \\[PCR\\] within 14 days prior to initiation of therapy. Participant who exhibit active uncontrolled infection on BTKi-R alone will not be excluded but would await adequate infection control and then get CAR T, as long as they have evidence of disease.\n42. Vaccinated with live, attenuated vaccines within 6 weeks of first dose of study drug.\n43. Any other serious medical condition including, but not limited to, clinically significant uncontrolled diabetes mellitus, COPD, renal failure, psychiatric illness or social circumstances that, in the investigator's opinion places the participant at unacceptable risk and would prevent the participant from signing the informed consent form or complying with study procedures.\n44. Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components.\n\n6\\. Concurrent participation in another therapeutic clinical trial. 47. Is unable to swallow any oral medication or has clinically significant gastrointestinal disease thatwould limit absorption of oral medication.\n\n48\\. . 49. Major surgical procedure within 28 days of first dose of study drug. Note: 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.\n\n50\\. Participants with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (antiHBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n\n1. History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n2. History of immunodeficiency (except for hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.",{"count":48,"type":19},30,[22],"to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.",[25,52,53,54,55],"MCL","BTKi","Rituximab","Glofitamab",{"date":57,"type":32},"2026-05-20",{"date":59,"type":32},"2026-04-01",{"date":61,"type":19},"2030-11-24",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":20,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100607721","phase-2-phase-2-study-to-assess-the-safety-and-efficacy-of-subcutaneous-blinatumomab-in-patients-with-measurable-residual-disease-positive-b-cell-acute-lymphoblastic-leukemia-100607721","NCT07192237","Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria\n\n* Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like).\n* ECOG Performance status of 0, 1, or 2.\n* Adequate organ function with creatinine less than or equal to 1.6 mg\u002Fdl, bilirubin less than or equal to 3.5 mg\u002Fdl and ALT and\u002For AST less than or equal to 5 times institutional upper limit of normal.\n* The effects of blinatumomab on the developing human fetus are unknown. For this reason and because bispecific T-cell engager agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Pregnant women are excluded from this study because Blinatumomab, a bispecific T-cell engager agent has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomb, breastfeeding should be discontinued if the mother is treated with blinatumomab. These potential risks may also apply to other agents used in this study.\n* Women of child-bearing potential (WOCBP) must have negative urine or serum pregnancy test within 1 week of study therapy initiation. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.\n* Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 4 months after the last dose of protocol specified therapy.\n* Symptomatic CNS leukemia\n* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including ICANS from prior CART or other T cell engager therapies.\n* Isolated extramedullary B-cell ALL\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Active acute or chronic graft versus host disease post-allogeneic HSCT requiring systemic treatment with immunosuppressive medication.\n* Prior history of therapy with SQ blinatumomab for R\u002FR B-cell as part of a clinical trial (but not prior therapy with IV blinatumomab)\n* Known hypersensitivity to blinatumomab or to any component of the product formulation\n* Uncontrolled HIV, HBV, HCV infections\n* Active and uncontrolled disease\u002Finfection as judged by the treating physician.\n* Unable or unwilling to sign the consent form.\n* No other investigational therapy within the past 14 days\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":70,"type":19},40,[22],"To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.",[25,74,75],"Blinatumomab","Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-04-29",{"date":79,"type":32},"2026-05-05",{"date":81,"type":19},"2026-09-27",{"date":83,"type":19},"2032-10-12",{"name":38,"class":39}]