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Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma

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. Identifier: NCT00294632
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : February 4, 2016
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both 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).

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Lenalidomide Drug: Rituximab Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2006
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Lenalidomide + Rituximab
Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
Drug: Lenalidomide
Starting Dose 10 mg By Mouth Daily on Days 1-21
Other Names:
  • CC-5013
  • Revlimid™

Drug: Rituximab
375 mg/m^2 By Vein Weekly for 4 Weeks
Other Name: Rituxan

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Lenalidomide in Combination with Rituximab i [ Time Frame: 28 days ]
    MTD is defined as the highest dose level in which 1 or fewer pts experienced a dose limiting toxicity (DLT) in 6 pts treated. DLT is any grade III or IV toxicity during the first 28 days (first cycle) of therapy.

Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 56 days ]
    Objective response rate defined as complete or partial response after 2 cycles of therapy maintained for one month. Objective response monitored using Simon's optimal 2-stage design.

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. 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).
  2. Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form.
  3. Age equal to or greater than 18 years at the time of signing the informed consent.
  4. Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
  6. 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.
  7. 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 (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 years.
  8. 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.
  9. Continuation from # 8 : (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.
  10. 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.
  11. Patients may have 1 to 4 lines of prior therapy for MCL (projected median 2 prior lines of therapy). Patient may or may not have received an anthracycline-based chemotherapy regimen.
  12. Patients must be willing to receive transfusions of blood products.
  13. Past stem cell (autologous or allogenic) transplantation is acceptable.
  14. Patients may have prior therapy with rituximab.

Exclusion Criteria:

  1. Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary 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.
  2. Pregnant or lactating females.
  3. 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.
  4. Known hypersensitivity to thalidomide or rituximab; including the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide.
  5. Prior use of lenalidomide.
  6. Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; not including patients with positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation.
  7. All patients with history of central nervous system lymphoma.
  8. Patients with peripheral blood involvement with white blood cell count (WBC) > 20,000 are EXCLUDED for the Phase I component of the study.
  9. Patients with >/= Grade 3 neuropathy.
  10. Patients with active pulmonary embolism or deep vein thrombosis (30 days within diagnosis).
  11. Patients with severe bradycardia (heart rate <40 bpm, hypotension, light-headedness, syncope).

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 identifier (NCT number): NCT00294632

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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Principal Investigator: Michael Wang, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00294632     History of Changes
Other Study ID Numbers: 2005-0461
NCI-2012-01356 ( Registry Identifier: NCI CTRP )
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by M.D. Anderson Cancer Center:
Mantle Cell Lymphoma
B-Cell Non-Hodgkin's Lymphoma
Transformed Large Cell Lymphoma
Follicular Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors