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

Sponsors and Collaborators:	Cancer and Leukemia Group B 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	Drug: lenalidomide Drug: rituximab	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
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

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
Arm I (closed to accrual as of 9/15/07): Active Comparator Patients receive rituximab IV on days 1, 8, 15, and 22.	Drug: rituximab Given IV
Arm II: Experimental 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
Arm III: Experimental 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.	Drug: lenalidomide Given orally Drug: rituximab Given IV

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 ≤ 2 times ULN (unless due to lymphoma)

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 47 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

John P. Leonard, MD

Weill Medical College of Cornell University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000442872, CALGB-50401
Study First Received:	October 12, 2005
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00238238
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

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lenalidomide
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009