Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
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ClinicalTrials.gov Identifier: NCT00262782 |
Recruitment Status :
Completed
First Posted : December 7, 2005
Last Update Posted : February 20, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia | Drug: Fludarabine | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 877 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia |
Study Start Date : | April 1997 |
Actual Primary Completion Date : | December 2004 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Fludarabine |
Drug: Fludarabine
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
Other Name: Fludura |
No Intervention: watch & wait |

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Confirmed diagnosis of B-cell chronic lymphocytic leukemia
- Rai stage 0-II (Binet stage A) disease
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Meets 1 of the following criteria:
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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
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Low-risk disease
- Meets none of the criteria (as listed above) for high-risk disease
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262782

Study Chair: | Michael Hallek, MD | Medizinische Universitaetsklinik I at the University of Cologne |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | German CLL Study Group |
ClinicalTrials.gov Identifier: | NCT00262782 |
Other Study ID Numbers: |
CLL1 EU-20548 GCLLSG-138 MEDAC-GCLLSG-CLL1 |
First Posted: | December 7, 2005 Key Record Dates |
Last Update Posted: | February 20, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Fludarabine Antineoplastic Agents |