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Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab

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: NCT00609869
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : September 1, 2014
Last Update Posted : September 17, 2015
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

Condition or disease Intervention/treatment Phase
Lymphocytic Leukemia Mantle Cell Lymphoma Drug: Lenalidomide Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Lenalidomide (REVLIMID®) in Combination With Rituximab for Patients With CD5+/CD20+ Hematologic Malignancies Who Relapse or Progress After Rituximab
Study Start Date : October 2007
Actual Primary Completion Date : February 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lenalidomide and Rituximab

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Drug: Lenalidomide
Lenalidomide was administered orally with escalating doses on 28-days cycles. The first cycle was administered with a starting dose of 2.5 mg daily on days 1-7, 5mg on days 8-14 and 10 mg on days 15-21, followed by seven days off. On cycle 2 and beyond lenalidomide was administered at 20 mg daily on days 1-21.
Other Name: REVLIMID®

Drug: Rituximab
Rituximab was administered at 375 mg/m^2 intravenously on a weekly basis for the first cycle starting on day 15. Subsequent rituximab doses were administered on day one of cycle 2 and beyond, every 4 weeks. Doses were repeated on 28-day cycles until disease progression or unacceptable toxicity, but were planned for 12 cycles.
Other Name: RITUXAN®

Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 6 years ]
    The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.

Secondary Outcome Measures :
  1. Clinical Benefit Rate [ Time Frame: Up to 6 years ]
    The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.

  2. Median Time to Treatment Failure (TTF) [ Time Frame: Up to 6 years ]
    The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.

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:

  • Have histologically or cytologically confirmed CD5+/CD20+ B-Cell Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
  • Meet the following CLL criteria to participate in this study:

    • Absolute lymphocyte count > 5000/μL
    • CD20+ and CD5+
    • Atypical cells representing < 55% on the peripheral smear
    • Bone marrow lymphocytes ≥ 30%
    • Or previous confirmed diagnosis of CLL/small lymphocytic lymphoma (SLL) with less than 5000/μl or less than 30% lymphocytes in BM
  • CLL Patients are eligible if they have stage III or IV disease. Patients with stage 0, I or II disease will be eligible if they have evidence of active disease defined as one or more of the following signs/symptoms:

    • Documented weight loss of ≥ 10% over a six month period
    • Febrile episodes of 38 degrees Celsius (100.5 degrees F) or greater for greater than 2 weeks without evidence of infection
    • Massive or progressive splenomegaly defined as > 6 cm below the left costal margin
    • Massive (> 10 cm in longest diameter) or progressive lymphadenopathy
  • Patients with progressive lymphadenopathy will need a biopsy of the lymphadenopathy within the previous six months to ensure that the disease entity remains chronic lymphocytic leukemia. Lymph node biopsy can be deferred if the patient does not have superficial lymphadenopathy that is easily accessible by surgery or by CT guided biopsy.
  • The diagnosis of MCL is based upon the National Comprehensive Cancer Network (NCCN) guidelines. The patient's will have biopsy proven CD5+/CD20+/CD23- mantle cell lymphoma with the characteristic cytogenetic abnormality t(11;14) or a cyclin D1 positive immunophenotype. If malignancy is CD23+ but FISH positive for t(11;14), diagnosis of mantle cell lymphoma can be made. Patients with mantle cell lymphoma require appropriate staging which would include upper and lower endoscopy within 2 months of enrollment per NCCN guidelines without additional treatment since the endoscopies.
  • Patients with MCL and CLL will be eligible if they have relapsed or progressive disease after Rituximab therapy or a combination therapy including Rituximab. Any other number of previous treatments is allowed including autologous or allogeneic bone marrow transplantation. Patients who are younger than age 65 who have not had a bone marrow transplant must be ineligible or have declined a bone marrow (BM) transplant to participate in this study. Although a transplant is not the standard of care for this patient population, it does provide the best opportunity for a cure.
  • Anticipated life expectancy of > 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Baseline organ and marrow function as follows:

    • Absolute neutrophil count ≥1,500/µL
    • Platelets ≥50,000/µL
    • Total bilirubin ≤2.0 mg/dL (34 µmol/L)
    • aspartic transaminase (AST)/alanine transaminase (ALT) ≤2.5 X institutional upper limit of normal(ULN)
    • Creatinine < institutional ULN OR
    • Creatinine clearance ≥60 mL/min/m² for patients with creatinine levels above institutional ULN
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. Women of childbearing potential, and men with a partner of childbearing potential must follow pregnancy test and birth control guidelines outlined for this study.
  • Ability to understand and the willingness to sign a written informed consent document
  • Able to adhere to the study visit schedule and other protocol requirements
  • Patients with uric acid levels > ULN at baseline must be corrected to ≤ULN prior to the initiation of study therapy.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • May not be receiving any other investigational agents
  • Known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide and/or thalidomide
  • Prior desquamating (blistering) rash with thalidomide
  • Neuropathy ≥ grade 2
  • Uncontrolled intercurrent illness including (not limited to) ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements.
  • Women currently pregnant or breastfeeding
  • Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
  • History of another malignancy besides CLL or MCL who have been disease-free ≤ 3 years with exception of basal cell or squamous cell carcinoma of skin or carcinoma in situ of cervix or breast
  • Any serious medical condition or psychiatric illness that will prevent patient from signing the informed consent form or will place the patient at unacceptable risk if he/she participates in the study
  • Prior use of lenalidomide
  • Prior severe hypersensitivity to Rituximab or other murine products

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): NCT00609869

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United States, Florida
Center for Cancer Care & Research/Watson
Lakeland, Florida, United States, 33805
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Celgene Corporation
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Principal Investigator: Javier Pinilla, M.D., PhD. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT00609869    
Other Study ID Numbers: MCC-14978
RV-CLL-PI-067 ( Other Identifier: Celgene )
First Posted: February 7, 2008    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 17, 2015
Last Verified: September 2015
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