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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00238238
First received: October 12, 2005
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Lymphoma
Biological: rituximab
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response rate (overall and complete) at 2, 4, 6, 9, 12, 15, 18, and 24 months, and then yearly for up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Time to progression for up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: March 2006
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238238

  Show 79 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: John P. Leonard, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00238238     History of Changes
Other Study ID Numbers: CDR0000442872, CALGB-50401, U10CA031946
Study First Received: October 12, 2005
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Rituximab
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014