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Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia


OBJECTIVES:

- Identify prognostic factors that predict a short survival in patients with stage 0-II
B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs
low risk). Patients in the low-risk group undergo observation only. Patients in the
high-risk group are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive fludarabine.

- Arm II: Patients undergo observation only.

PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of B-cell chronic lymphocytic leukemia

- Rai stage 0-II (Binet stage A) disease

- Meets 1 of the following criteria:

- High-risk disease, as defined by the following:

- Serum thymidine kinase level > 7.0 U/L

- Elevated β2-microglobulin level

- Presence of non-nodular bone marrow infiltration

- Short lymphocyte doubling time

- Low-risk disease

- Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

- Not specified

Life expectancy

- More than 6 months

Hematopoietic

- No autoimmune hemolytic anemia

- No thrombocytopenia

Hepatic

- Not specified

Renal

- Not specified

Other

- No severe organ dysfunction

- No other prior or concurrent malignancy

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael Hallek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medizinische Universitaetsklinik I at the University of Cologne

Authority:

United States: Federal Government

Study ID:

CDR0000455035

NCT ID:

NCT00262782

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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