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Trial record 26 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

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: NCT00860457
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : August 18, 2014
Last Update Posted : November 21, 2018
Celgene Corporation
Information provided by (Responsible Party):
Georgetown University

Brief Summary:

This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease.

Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this research because we are attempting to improve the response, or outcome, of Fludarabine and Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

This research is being done because we are attempting to find a better treatment for chronic lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of Fludarabine and Rituximab.

The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and Rituximab alone.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Rituximab Drug: Fludarabine Drug: Lenalidomide Phase 2

Detailed Description:

This is a single institution Phase II study where all enrolled patients with untreated CLL will receive fludarabine and rituximab (FR) combination therapy. Subjects who demonstrate Stable disease or Progressive disease after completing 3 cycles of FR will receive lenalidomide monotherapy for a maximum of 6 cycles. Subjects who achieve >/= PR after receiving 3 cycles of FR will receive 3 additional cycles of FR (maximum of 6 cycles). Upon completion of FR treatment subjects will receive lenalidomide monotherapy for a maximum of 6 cycles.

Response assessment will be performed for Module A (FR): after every cycle, but would include imaging after cycle 3 if clinically indicated. Response assessment will be performed for Module B (Lenalidomide monotherapy): Before starting Lenalidomide therapy, after every cycle and on completion of therapy. Imaging for Module B would be obtained before starting lenalidomide therapy, and on completion of therapy. Bone marrow biopsies will be performed prior to starting therapy in Module A (FR), prior to starting Module B (Lenalidomide), and on completion of Module B. Bone marrow biopsies can be obtained once during Lenalidomide therapy at the discretion of the investigator. Minimum residual disease assessment of bone marrow specimens should include immunohistochemistries and flow cytometry. Additional studies on bone marrow specimens will be sent for flow cytometric analysis (standard or four color flow), ZAP-70 immunohistochemical stains and FISH analysis (13q deletion, trisomy 12, 11q deletion, and 17p) will be performed at the time intervals described above.

Response will be assessed according to the Cheson Criteria.

Blood specimens for optional correlative studies will be drawn on Day 0 prior to FR, prior to starting lenalidomide, 90 days after initiation of lenalidomide, and 7 days after the last dose of lenalidomide.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lenalidomide Following Rituximab and Fludarabine in Untreated Chronic Lymphocytic Leukemia
Study Start Date : February 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: Chemotherapy
Fludarabine/Rituximab followed by Lenalidomide
Drug: Rituximab
375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles
Other Name: Rituxan

Drug: Fludarabine
25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles
Other Name: Fludara

Drug: Lenalidomide
5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Other Name: Revlimid

Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: 3 years ]
    Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.

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:

  • Understand and voluntarily sign informed consent form
  • No prior therapy for CLL
  • Able to adhere to study visit schedule and other protocol requirements
  • CLL with any Rai Stage requiring therapy
  • ECOG performance status </= 2
  • Absolute neutrophil count >/= 1.0
  • Platelet count >/= 75
  • Serum creatinine </= 1.5
  • Total bilirubin </= 1.5
  • AST and ALT </= 2 x ULN
  • Females of childbearing potential must have negative pregnancy test
  • Disease free of prior malignancies for >/= 5 years
  • Able to take aspirin daily as prophylactic anticoagulation

Exclusion Criteria:

  • Any serious medical condition, lab abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Pregnant or lactating females
  • Any condition, including the presence of lab abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  • Use of any other experimental drug or therapy within 28 days of baseline
  • Concurrent use of other anti-cancer agents or treatments
  • Known positive for HIV or infectious active hepatitis, type A, B
  • Known hypersensitivity to nucleoside analogue or rituximab
  • Previous treatment for CLL prior to enrolling in study
  • Known hypersensitivity to thalidomide
  • The development of erythema nodosum if characterized by desquamating rash while taking thalidomide or similar drugs
  • Any prior use of lenalidomide
  • Active hemolysis

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): NCT00860457

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United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Celgene Corporation
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Principal Investigator: Bruce D Cheson, MD Georgetown University

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Responsible Party: Georgetown University Identifier: NCT00860457     History of Changes
Other Study ID Numbers: RV-CLL-PI-089
First Posted: March 12, 2009    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: November 21, 2018
Last Verified: August 2014
Keywords provided by Georgetown University:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Antiviral Agents
Anti-Infective Agents