Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Palo Alto, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01886859
Phase
PHASE1
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Lenalidomide — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Apr 26, 2013
Status verified
Sep 2022
Primary completion
Nov 15, 2020
Completion
Sep 21, 2022

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ibrutinib and lenalidomide)
    Patients receive a run-up cycle of ibrutinib 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 CR/CRi, nodular PR, partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib.

Primary Outcome Measure

Maximum tolerated dose of lenalidomide when combined with ibrutinib [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
University of Colorado HospitalAuroraColorado80045-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Institute Palo Alto· Palo Alto, CAUniversity of Colorado Hospital· Aurora, COOhio State University Comprehensive Cancer Center· Columbus, OH

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