Completed

NCT Number: NCT00262782

Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik, Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludarabine

Drug

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

Other names: Fludura

Sponsors and collaborators

Lead sponsor

German CLL Study Group

Other

Registry information

Official study title

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

Important dates

Study start: 1997
Primary completion: 2004
Study completion: 2010
First posted: Dec 7, 2005
Registry last updated: Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed