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A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia


- 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

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Responders (Complete and Partial Response)

Outcome Description:

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.)

Outcome Time Frame:

4 weeks, every 3 months for 2 years, and then every 4 months for 2 years

Safety Issue:


Principal Investigator

Kelvin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

May 2012

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Roswell Park Cancer Institute Buffalo, New York  14263