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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

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

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

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
[GM-CSF])

- 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:

Interventional

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:

Yes

Principal Investigator

Richard Furman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02393

NCT ID:

NCT00009984

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

Name

Location

Montefiore Medical Center Bronx, New York  10467-2490