Trial | NCT00262782  Report issue

Title

Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    877
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell 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.
Study Started
Apr 30
1997
Primary Completion
Dec 31
2004
Study Completion
Jun 30
2010
Last Update
Feb 20
2020

Drug Fludarabine

Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles

  • Other names: Fludura

Fludarabine Experimental

watch & wait No Intervention

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
No Results Posted