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Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine

Phase 2
18 Years
Not Enrolling
Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia

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Trial Information

Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine


I. Compare the safety and tolerability of thalidomide with or without fludarabine in
patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic

II. Compare the incidence of complete and partial remission in patients treated with these

OUTLINE: This is a randomized, open-label study. Patients are stratified according to time
to relapse from last fludarabine treatment (less than 6 months vs more than 6 months).
Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral thalidomide once daily in the absence of disease progression or
unacceptable toxicity.

Arm II: Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days
1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is
completed, patients continue to receive thalidomide alone as in arm I.

PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for
this study within 1 year.

Inclusion Criteria:

- Diagnosis of one of the following:

- Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria:

- Peripheral blood lymphocytosis greater than 5,000/mm^3

- Co-expression of the CD5, CD19, CD20, and CD23 surface antigens

- Clonal kappa and lambda light chain expression

- Dim surface immunoglobulin expression

- Small lymphocytic lymphoma

- Relapsed or refractory disease

- Must have received at least 1 prior regimen containing fludarabine

- Meets one of the following criteria:

- Recurrence of lymphocytosis greater than 5,000/mm^3 or an increase in lymph
node volume greater than 50% after achieving complete (CR) or partial
response (PR)

- Never achieved a CR or PR after receiving at least 2 courses of fludarabine
IV for 5 days at a dose of 25 mg/m^2/day

- No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g.,
prolymphocytic leukemia or Richter's syndrome)

- No known CNS disease

- Performance status - Karnofsky 60-100%

- At least 12 weeks

- See Disease Characteristics

- Bilirubin < 2.0 times upper limit of normal (ULN)*

- SGOT < 2.5 times ULN*

- Creatinine < 1.5 times ULN

- No history of cardiac arrhythmia

- No myocardial infarction within the past 6 months

- 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 pre-existing neurotoxicity grade 3 or greater

- No other medical condition that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Female patients must use 2 effective methods (at least 1 highly active method) of
contraception 4 weeks before, during, and for 4 weeks after study participation and
male patients must use effective barrier contraception during and for 4 weeks after
study participation

- At least 4 weeks since prior biologic therapy and recovered

- No concurrent growth factors (epoetin alfa, filgrastim [G-CSF], or sargramostim

- See Disease Characteristics

- No more than 3 prior chemotherapy regimens

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No other concurrent chemotherapy

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

- Recovered from any prior investigational agents

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Richard Furman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



Montefiore Medical Center Bronx, New York  10467-2490