NCT02225275

Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well lenalidomide and obinutuzumab work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and obinutuzumab may work better in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. Overall response defined as achievement of complete response (CR) or partial response (PR). SECONDARY OBJECTIVES: I. Safety of the combination. II. Response according to prognostic markers at diagnosis. III. Time to next treatment. IV. Overall survival. OUTLINE: Patients receive obinutuzumab intravenously (IV) over 3-4 hours on days 1, 2, 8, and 15 of course 1 and day 1 of courses 2-6 and lenalidomide orally (PO) once daily (QD) on days 9-28 of course 1 and days 1-28 of all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive lenalidomide PO QD in the absence of disease progression or unacceptable toxicity.

Conditions

• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Given PO
BIOLOGICAL	Obinutuzumab	Given IV

Timeline

• Start date: 2016-03-31
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2014-08-26
• Last updated: 2022-09-28
• Results posted: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study