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Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00294632
  Purpose

Primary Objectives:

  1. To evaluate the safety of lenalidomide in combination with rituximab in patients with relapsed/refractory mantle cell lymphoma (MCL) and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
  2. To evaluate the response rate of lenalidomide in combination with rituximab in patients with relapsed or refractory mantle cell lymphoma and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
  3. To evaluate the survival of mantle cell lymphoma patients treated with lenalidomide and rituximab and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).

Condition Intervention Phase
Lymphoma
Drug: Lenalidomide
Drug: Rituximab
Phase I
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, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Lenalidomide and Rituximab Treatment of Relapsed Mantle Cell Lymphoma and Diffuse Large B-Cell Non-Hodgkin's Lymphoma, Transformed Large Cell Lymphoma, and/or Grade 3 Follicular Lymphoma (Follicular Cleaved Large Cell Lymphoma or Follicular Non-Cleaved Large Cell Lymphoma (RV-LYM-PI-0056)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find the highest tolerable dose of the drug lenalidomide (CC-5013) that can be given with Rituxan (rituximab) in the treatment of relapsed mantle cell lymphoma. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: February 2006
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Lenalidomide + Rituximab
Drug: Lenalidomide
10 mg PO Daily on Days 1-21
Drug: Rituximab
375 mg/m^2 IV Weekly x 4 Weeks

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Phase I and Phase II: Confirmed diagnosis of mantle cell lymphoma with CD20 positivity in tissue biopsy. Patients must have previously treated relapsed and/or refractory MCL. Or for Phase II: Confirmed diagnosis of previously treated relapsed and/or refractory diffuse large B-cell lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
  • Understand and voluntarily sign an IRB-approved informed consent form.
  • Age equal to or greater than 18 years at the time of signing the informed consent.
  • Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
  • Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl; platelet count >75,000/mm^3 and absolute neutrophil count (ANC) > 1,000/mm^3. AST (SGOT) and ALT (SGPT) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present.
  • Disease free of prior malignancies of equal to or greater than 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission, not actively being treated, with a life expectancy > 3 years.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test 10-14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide.(HIGHLY EFFECTIVE METHODS - Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, partner's vasectomy. ADDITIONAL EFFECTIVE METHOD-latex condom, diaphragm, cervical cap) while on study drug.
  • WCBP must agree to have pregnancy tests every week for the first 4 weeks of treatment, then every 4 weeks if her menstrual cycles are regular or every 2 weeks if her cycles are irregular, while on study drug, and 4 weeks after the last dose of study drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
  • Patients may have 1 to 4 lines of prior therapy for MCL (projected median 2 prior lines of therapy). Patients must have failed an anthracycline-based chemotherapy regimen.
  • Patients must be willing to receive transfusions of blood products.
  • Past stem cell (autologous or allogenic) transplantation is acceptable.
  • Patients may have prior therapy with rituximab.

Exclusion Criteria:

  • Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, coronary artery disease, COPD, renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. Patients with history of cardiac arrythmias should have cardiac evaluation and clearance.
  • Pregnant or lactating females.
  • Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment.
  • Known hypersensitivity to thalidomide or rituximab; including the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide.
  • Prior use of lenalidomide.
  • Known HIV infection, or infectious hepatitis, type B or C. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination who are positive for serum hepatitis B antibody).
  • All patients with history of central nervous system lymphoma.
  • Patients with peripheral blood involvement with WBC > 20,000 are EXCLUDED for the Phase I component of the study.
  • Patients with >/= Grade 3 neuropathy.
  • Patients with active pulmonary embolism or deep vein thrombosis (30 days within diagnosis).
  • Patients with severe bradycardia (heart rate <40 bpm, hypotension, light-headedness, syncope).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294632

Contacts
Contact: Michael Wang, MD 713-792-2860
Contact: Ginger Beasley, RN 713-792-3610

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael Wang, MD     713-792-2860        
Contact: Ginger Beasley, RN     713-792-3610        
Principal Investigator: Michael Wang, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Michael Wang, MD UT MD Anderson Cancer Center
  More Information

UT MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Michael Wang, MD/Assistant Professor )
Study ID Numbers: 2005-0461
Study First Received: February 20, 2006
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00294632  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Mantle Cell Lymphoma
B-Cell Non-Hodgkin's Lymphoma
Transformed Large Cell Lymphoma
Follicular Lymphoma
Lymphoma
MCL
Lenalidomide
CC-5013
Revlimid™
Rituximab
Rituxan

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Lenalidomide
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Mantle cell lymphoma
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

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 16, 2009