A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NCT04694560 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2025-05-16
Summary
The purpose of this study is to find out whether people with CLL or SLL who are currently receiving treatment with ibrutinib can stop treatment and remain off-treatment for at least 12 months, if they have achieved complete or partial remission of their disease.
Conditions
Interventions
- OTHER
-
Treatment Free Observation
Participants without evidence of clinical relapse will remain off therapy and continue serial monitoring through end of study at 24 cycles. Participants with clinical relapse will continue to be monitored off therapy through 24 cycles or until meeting criteria for treatment per iwCLL criteria. If participants experience clinical relapse requiring treatment, radiology assessment, disease assessment, and testing for resistance mutations will be performed. Participants will be observed for an additional 12 cycles following start of reintroduction of therapy.
Sponsors & Collaborators
-
Pharmacyclics LLC.
collaborator INDUSTRY -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Anthony Mato, MD · Memorial Sloan Kettering Cancer Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-12-22
- Primary Completion
- 2023-03-06
- Completion
- 2023-03-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma
NCT02269085 ·Status: TERMINATED ·Phase: PHASE1
-
Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL
NCT01722487 ·Status: COMPLETED ·Phase: PHASE3
-
Ipilimumab in Treating Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT01757639 ·Status: COMPLETED ·Phase: PHASE1
-
Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
NCT02611908 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT02264574 ·Status: COMPLETED ·Phase: PHASE3
-
Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT03516617 ·Status: RECRUITING ·Phase: PHASE2
-
Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02518555 ·Status: COMPLETED ·Phase: PHASE2
-
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
NCT01744665 ·Status: COMPLETED ·Phase: PHASE2
-
Ibrutinib in Previously Untreated Binet Stage a Chronic Lymphocytic Leukemia with Risk of Disease Progression
NCT02863718 ·Status: COMPLETED ·Phase: PHASE3
-
Early Intervention With Acalabrutinib in Patients With High Risk CLL
NCT04660045 ·Status: WITHDRAWN ·Phase: PHASE2
-
Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia
NCT02997761 ·Status: COMPLETED ·Phase: PHASE2
-
Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant
NCT03267186 ·Status: COMPLETED ·Phase: PHASE2
-
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT03204188 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
NCT02514083 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
NCT01589302 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
NCT02351037 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Small Lymphocytic Lymphoma (SLL)
NCT01005979 ·Status: TERMINATED ·Phase: PHASE1
-
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT01886859 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Trial GA101 Inbrutinib B CLL
NCT02666898 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia
NCT02251548 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT06757647 ·Status: RECRUITING ·Phase: PHASE2
-
REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy
NCT05621148 ·Status: COMPLETED
-
Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02437019 ·Status: APPROVED_FOR_MARKETING
-
Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
NCT02677948 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02556346 ·Status: WITHDRAWN ·Phase: PHASE1