Spots Global Cancer Trial Database for 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

Study Description

Brief Summary: This phase II trial studies how well ibrutinib or idelalisib works in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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