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Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia

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: NCT00096018
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : March 5, 2013
Last Update Posted : October 24, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: fludarabine phosphate Drug: thalidomide Phase 1 Phase 2

Detailed Description:


  • Determine the safety and efficacy of fludarabine and thalidomide in patients with newly diagnosed B-cell chronic lymphocytic leukemia.
  • Determine the overall response rate (complete and partial) in patients treated with this regimen.
  • Determine the duration of response in patients treated with this regimen.

OUTLINE: This is an open-label, phase I, dose-escalation study of thalidomide followed by a phase II study.

  • Phase I: Beginning on day 1, patients receive oral thalidomide once daily for up to 6 months. Beginning on day 7, patients also receive fludarabine IV over 30 minutes daily for 5 days. Treatment with fludarabine repeats every 28-35 days for up to 6 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive fludarabine and thalidomide as in phase I at the MTD.

Patients are followed at 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years.

PROJECTED ACCRUAL: Up to 45 patients (≥ 9 for the phase I portion and ≤ 36 for the phase II portion) will be accrued for this study within 8 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia
Study Start Date : May 2002
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: Dose escalation
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days
Drug: fludarabine phosphate
Given IV

Drug: thalidomide

Primary Outcome Measures :
  1. Overall Responders (Complete and Partial Response) [ Time Frame: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years ]
    Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)

  2. Duration of Response [ Time Frame: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) based on the following criteria:

    • Peripheral blood lymphocytosis > 5,000/mm^3
    • Co-expression of CD5, CD19 or CD20, and CD23 surface antigens
    • Clonal kappa or lambda light chain expression
  • No recurrent or refractory CLL
  • No other lymphoproliferative diseases or diseases due to transformation of CLL, such as prolymphocytic leukemia or Richter's syndrome



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 12 weeks


  • See Disease Characteristics


  • Bilirubin < 1.5 mg/dL
  • AST < 2.5 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL


  • No cardiac arrhythmia within the past 6 months
  • No myocardial infarction within the past 6 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use at least 1 highly active and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study treatment
  • Patients must have sufficient mental capacity to understand the study explanation and provide informed consent
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No active serious infection uncontrolled by antibiotics
  • No medical condition or reason that would preclude study participation


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No prior therapy for CLL

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): NCT00096018

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
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Principal Investigator: Kelvin Lee, MD Roswell Park Cancer Institute
Publications of Results:
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Responsible Party: Roswell Park Cancer Institute Identifier: NCT00096018    
Other Study ID Numbers: CDR0000391769
First Posted: November 9, 2004    Key Record Dates
Results First Posted: March 5, 2013
Last Update Posted: October 24, 2013
Last Verified: September 2013
Keywords provided by Roswell Park Cancer Institute:
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors