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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 currently recruiting participants.
Verified March 2011 by National Cancer Institute (NCI)

First Received on October 12, 2005.   Last Updated on March 26, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00238238
  Purpose

RATIONALE: 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.

PURPOSE: 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
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 National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]
  • Time to progression for up to 10 years [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2006
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (closed to accrual as of 9/15/07)
Patients receive rituximab IV on days 1, 8, 15, and 22.
Biological: rituximab
Given IV
Experimental: Arm II
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
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.
Biological: rituximab
Given IV
Drug: lenalidomide
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Compare the overall and complete response rate in patients with follicular non-Hodgkin's lymphoma that has relapsed after treatment with rituximab and/or lenalidomide.
  • Compare time to progression (TTP) in patients treated with these regimens.

Secondary

  • Compare TTP after prior rituximab-based combination therapy vs TTP in patients treated with these regimens.
  • Determine the toxicity profile of these regimens in these patients.
  • Correlate Fc-receptor-polymorphism profiling with response in patients treated with these regimens.
  • Correlate changes in natural killer (NK) cells, activated NK cells, activated T-cells, and several plasma cytokines after exposure to lenalidomide therapy, followed by rituximab, with objective response rate in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I (closed to accrual as of 9/15/07): Patients receive rituximab IV on days 1, 8, 15, and 22.
  • Arm II: 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.
  • Arm III: Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, and 22 of course 1 and day 1 of course 2 of lenalidomide.

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

PROJECTED ACCRUAL: A total of 180 patients (90 for arm I [closed to accrual as of 9/15/07], 45 each for arms II and III) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically* confirmed follicular non-Hodgkin's lymphoma

    • Grade 1, 2, or 3a disease (> 15 centroblasts per high-power field with centrocytes present) NOTE: *Bone marrow biopsy as the sole means of diagnosis is not acceptable; fine-needle aspirates are not acceptable
  • Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
  • Measurable disease > 1 cm

    • No non-measurable disease only, including any of the following:

      • Bone lesions
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Bone marrow involvement
  • Must have been treated with rituximab either alone or in combination with chemotherapy

    • Time to disease progression ≥ 6 months after last rituximab dose
    • Last prior treatment regimen need not include rituximab
  • No known CNS involvement

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or lymphoma)

Renal

  • Creatinine < 1.5 times ULN (unless due to lymphoma) OR creatinine clearance > 30 mL/minute (patients on dialysis not allowed)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No "currently active" secondary malignancy (e.g., Waldenstrom's macroglobulinemia) except nonmelanoma skin cancer

    • Patients are not considered to have a "currently active" second malignancy if they have completed anticancer therapy and are deemed to have < 30% risk of relapse by their physician
  • No deep vein thrombosis or pulmonary embolism within the past 3 months

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • See Radiotherapy

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • More than 2 weeks since prior corticosteroids except for maintenance therapy (at a dose ≤ 20 mg/day) for a nonmalignant disease
  • No concurrent hormonal therapy except for the following:

    • Steroids for adrenal failure
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroids as antiemetics

    • Concurrent dexamethasone for infusion reactions allowed

Radiotherapy

  • No radioimmunotherapy within 12 months of study entry

Other

  • No other concurrent investigational or commercial agents or therapies for lymphoma
  Contacts and Locations
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: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00238238     History of Changes
Other Study ID Numbers: CDR0000442872, CALGB-50401
Study First Received: October 12, 2005
Last Updated: March 26, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Thalidomide
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 14, 2012