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Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238238
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : February 7, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: lenalidomide Phase 2

Detailed Description:

Outline:

This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary objectives of the study are provided below.

Primary Objectives:

  • To determine the response rate (overall and complete) after lenalidomide therapy and rituximab + lenalidomide in follicular NHL patients who have relapsed.
  • To determine time to progression after lenalidomide therapy and rituximab and lenalidomide in follicular NHL patients who have relapsed.

Secondary Objectives:

  • To compare the time to progression of the previous rituximab regimen to that obtained subsequently to lenalidomide therapy and rituximab + lenalidomide.
  • To determine the toxicity profile of lenalidomide therapy and of rituximab and lenalidomide in follicular NHL patients who have received a previous rituximab regimen.
  • To correlate Fc receptor polymorphism profiling with response to lenalidomide or rituximab + lenalidomide in previously treated patients with follicular NHL who have relapsed.
  • To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells and several plasma cytokines followed by rituximab therapy and correlation of observed changes to objective response rates.

After completion of study treatment, patients are followed for up to 10 years from study entry.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory
Study Start Date : March 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I - rituximab
Patients receive rituximab IV on days 1, 8, 15, and 22.
 Biological: rituximab
Given IV
Experimental: Arm II - lenalidomide
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
 Drug: lenalidomide
Given orally
Experimental: Arm III - lenalidomide and rituximab
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.
 Biological: rituximab
Given IV

Drug: lenalidomide
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Duration of treatment (12 cycles) ]
    Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.

  2. Time to Progression [ Time Frame: Up to 10 years ]
    Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

  • Documentation of Disease

    • Previously treated, histologically confirmed follicle center cell lymphoma, World Health Organization (WHO) classification, grade 1, 2, or 3a
    • Institutional flow cytometry or immunohistochemistry must confirm Cluster of Differentiation 20 (CD20) antigen expression.

  • Prior Treatment

    • Patient must have been treated with rituximab either alone or in combination with chemotherapy.
    • Patient must have a time to progression of ≥ 6 months from last rituximab dose.
    • No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent.
    • No prior radioimmunotherapy within 12 months of study entry.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

  • Measurable disease must be present either on physical examination or imaging studies. Non-measurable disease alone is not acceptable. Any tumor mass >1 cm is acceptable.Lesions that are considered non-measurable include the following:

    • Bone lesions
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Bone marrow
  • No known Central Nervous System (CNS) involvement by lymphoma.
  • No known Human Immunodeficiency Virus (HIV) infection.
  • Non-pregnant and non-nursing.
  • Patients with a "currently active" second malignancy, other than non-melanoma skin cancers, are not eligible.
  • Patients with a recent history (within 3 months of study entry) of Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) are not eligible.

  • Required Initial Laboratory Values:

    • Absolute Neutrophil Count (ANC) ≥ 1000/µL
    • Platelet count ≥ 75,000/µL
    • Creatinine < 1.5 x Upper Limit of Normal (ULN) unless attributed to lymphoma or calculated clearance > 50 mL/min (patients on dialysis are not eligible)
    • Total Bilirubin ≤ 2 x ULN unless attributed to lymphoma or Gilbert's disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238238


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: John P. Leonard, MD Weill Medical College of Cornell University
More Information
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Publications of Results:

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00238238    
Other Study ID Numbers: CALGB-50401
CALGB-50401
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000442872 ( Registry Identifier: NCI Physician Data Query )
First Posted: October 13, 2005    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: March 15, 2017
Last Verified: February 2017
Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
 Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors