Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT01419795
Brief Summary:
This phase II trial studies how well giving lenalidomide with or without rituximab works in treating patients with progressive or relapsed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia (PLL), or non-Hodgkin lymphoma (NHL). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with or without rituximab may kill more cancer cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To improve overall survival in patients with relapse of NHL or CLL/SLL/PLL within 180 days after allogeneic hematopoietic cell transplant (HCT).
SECONDARY OBJECTIVES:
I. Rate of response (complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) and time to progression.
II. Grade III-IV toxicity.
III. Incidences of grades II-IV acute graft-versus-host disease (GVHD) and limited or extensive chronic GVHD.
IV. Compare efficacy and safety between the first, second and third cohorts.
V. Laboratory research studies for efficacy and toxicity: blood samples will be stored at baseline, day 7, and day 28 of cycle 1 and day 28 of cycle 3 to investigate:
1. changes in plasma cytokines and peripheral blood lymphocytes in correlation to treatment with lenalidomide;
2. pharmacokinetics of rituximab;
3. donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide orally (PO) once daily (QD) on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.
ARM II: Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 and 60 days and then every 3 months for up to 18 months.
Study:
NCT01419795
Study Brief:
Protocol Section:
NCT01419795