Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant
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|ClinicalTrials.gov Identifier: NCT02662296|
Recruitment Status : Withdrawn (Low enrollment)
First Posted : January 25, 2016
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prolymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma||Drug: Ibrutinib Drug: Idelalisib||Phase 2|
I. To improve the outcomes of patients who have progressed or relapsed lymphoma or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)/prolymphocytic leukemia (PLL) within 180 days following allogeneic hematopoietic cell transplant (HCT) compared to historical data: 12-month overall survival.
I. To describe the safety profile observed in these populations.
II. Estimate the overall response rate (complete response [CR] + partial response [PR]) by standard morphologic, flow cytometric, imaging, and molecular techniques.
III. Assess progression free-survival.
IV. Define incidences of grade III-IV toxicities and infections.
V. Estimate incidence of relapse and non-relapse mortality.
VI. Estimate incidences of grade II-III and III-IV acute graft-versus-host disease (GVHD) and chronic GVHD.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 or idelalisib PO twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Non-Randomized, Single Institution, Clinical Trial of Signal Transduction Inhibitors, Ibrutinib or Idelalisib, to Treat Patients With Persistent or Relapsed B-Cell Malignancies Following Allogeneic Hematopoietic Cell Transplantation|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||February 2022|
Experimental: Treatment (ibrutinib or idelalisib)
Patients receive ibrutinib PO QD on days 1-28 or idelalisib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall survival (OS) (Cohort I) [ Time Frame: 12 months ]OS will be estimated using the Kaplan-Meier method.
- Incidence of grade III-IV adverse events using the National Cancer Institute Common Toxicity Criteria version 4.0 (Cohort I and Cohort II) [ Time Frame: Up to 30 days post-treatment ]Toxicities among the 2 cohorts will be compared to those reported in the literature after using ibrutinib or idelalisib for relapsed CLL/lymphoma before transplant.
- OS (Cohort I and Cohort II) [ Time Frame: Up to 6 years ]OS will be estimated using the Kaplan-Meier method in all cohorts.
- Progression free-survival (PFS) (Cohort I and Cohort II) [ Time Frame: Up to 6 years ]PFS will be estimated using the Kaplan-Meier method in all cohorts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662296
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Mohamed Sorror||Fred Hutch/University of Washington Cancer Consortium|