Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
40

Summary

Conditions
  • Recurrent B-Cell Prolymphocytic Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory B-Cell Prolymphocytic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
18
Max Age
125
Gender
Both

Description

PRIMARY OBJECTIVE: I. To define the safety, tolerability and maximum tolerated dose (MTD) of lenalidomide when used in combination with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). SECONDARY OBJECTIVES: I. To determine the respo...

PRIMARY OBJECTIVE: I. To define the safety, tolerability and maximum tolerated dose (MTD) of lenalidomide when used in combination with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). SECONDARY OBJECTIVES: I. To determine the response rate and response duration in relapsed and refractory CLL/SLL patients with ibrutinib and lenalidomide. II. To characterize the plasma pharmacokinetic (PK) interaction between ibrutinib and lenalidomide. III. To explore whether pharmacogenetic studies can predict response, resistance or toxicity to ibrutinib and lenalidomide. IV. To explore the ability of ibrutinib to occupy its targets (Bruton's tyrosine kinase [BTK] in B-cells and interleukin-2 inducible kinase [ITK] in T-cells), and whether co-administration with lenalidomide influences this binding. V. To explore the early and late immunologic consequences of combining ibrutinib with lenalidomide in relapsed and refractory CLL. VI. To explore the impact of ibrutinib and lenalidomide on ras homolog family member H (RhoH) expression and whether baseline RhoH expression predicts outcomes with this regimen. VII. To explore mechanisms of resistance to ibrutinib. VIII. To explore the influence of traditional and new CLL/SLL clinical and laboratory prognostic factors on response to ibrutinib and lenalidomide. OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive a run-up cycle of ibrutinib orally (PO) daily on days 1-28. Patients then receive ibrutinib PO and lenalidomide PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients who have achieved complete remission (CR)/CR with incomplete marrow recovery (CRi), nodular partial remission (PR), partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib. After completion of study treatment, patients are followed up for 90 days.

Locations

Palo Alto, California, 94304
Columbus, Ohio, 43210
Aurora, Colorado, 80045
Palo Alto, California, 94304
Columbus, Ohio, 43210
Aurora, Colorado, 80045

Tracking Information

NCT #
NCT01886859
Collaborators
Not Provided
Investigators
  • Principal Investigator: Daniel A Pollyea University of Colorado, Denver
  • Daniel A Pollyea University of Colorado, Denver