Lenalidomide With or Without Rituximab in Treating Patients With Progressive or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, or Non-Hodgkin Lymphoma Previously Treated With Donor Stem Cell Transplant

This study is currently recruiting participants.
Verified July 2012 by Fred Hutchinson Cancer Research Center

First Received on August 15, 2011.  
Last Updated on July 31, 2012  
History of Changes
This Clinical Trial Sponsored By: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01419795
 

Purpose for Clinical Trial

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

Condition Study Intervention Clinical Trial Phase
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Prolymphocytic Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Drug: lenalidomide
Biological: rituximab
Other: pharmacological study
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Investigating Treatment of Post-Allogeneic Transplant Progression or Relapse of CLL/SLL/PLL or NHL With Lenalidomide Alone or With Rituximab

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Chronic Lymphocytic Leukemia
Fungal Infections
Leukemia
Lymphoma
Drug Information available for:
Rituximab
Lenalidomide

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures For Clinical Trial:

  • Improvement in overall survival of patients receiving lenalidomide with or without rituximab in comparison to historical controls managed by single or multiple chemotherapeutic agents or donor lymphocyte infusion (DLI) (Cohort 1) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method in all cohorts.

Secondary Outcome Measures For Clinical Trial:

  • Rate of response (CR, PR, or SD) and time to progression [ Time Frame: Assessed up to 18 months ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method in all cohorts.

  • Grade III-IV toxicity in patients receiving lenalidomide with or without rituximab [ Time Frame: Assessed up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Incidences of grades II-IV acute GVHD and limited or extensive chronic GVHD [ Time Frame: Assessed up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
  • Comparison of rates of overall response and complete remission between the first, second, and third cohorts [ Time Frame: Assessed up to 18 months ] [ Designated as safety issue: No ]
  • Changes in plasma cytokines and peripheral blood lymphocytes in correlation to treatment with lenalidomide [ Time Frame: From baseline to day 28 of course 3 ] [ Designated as safety issue: No ]
  • Comparison of incidences of adverse events between the first, second, and third cohorts [ Time Frame: Assessed up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of rituximab: evaluation of serum concentrations and correlations to drug dose and clinical responses [ Time Frame: Baseline, day 7, and day 28 of course 1 and day 28 of course 3 ] [ Designated as safety issue: No ]
  • Donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse [ Time Frame: Day 7 of course 1 ] [ Designated as safety issue: No ]
  • Donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse [ Time Frame: Day 28 of course 1 ] [ Designated as safety issue: No ]
  • Donor and host polymorphisms of the FCgamma RIIIa receptor and their impact on disease response and relapse [ Time Frame: Day 28 of course 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

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