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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00262782

First Posted: December 7, 2005

Last Update Posted: September 13, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

German CLL Study Group

Purpose

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	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: Fludarabine	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Fludarabine Fludarabine phosphate

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Further study details as provided by German CLL Study Group:


Enrollment:	877
Study Start Date:	April 1997
Study Completion Date:	June 2010
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

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

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Show 117 Study Locations

Sponsors and Collaborators

German CLL Study Group

Investigators


Study Chair:	Michael Hallek, MD	Medizinische Universitaetsklinik I at the University of Cologne

More Information

Additional Information:

Click here for more information about this study: CLL1 (German CLL Study Group) This link exits the ClinicalTrials.gov site

Publications:

Bergmann MA, Eichhorst BF, Busch R, et al.: Early and risk-adapted therapy with fludarabine in high-risk Binet stage A CLL patients prolongs progression free survival but not overall survival: results of the CLL1 protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.

Bergmann MA, Eichhorst BF, Busch R, et al.: Prospective evaluation of prognostic parameters in early stage chronic lymphocytic leukemia (CLL): results of the CLL1-protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-625, 2007.

Hoechstetter MA, Busch R, Eichhorst B, Bühler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jäger U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Müller L, Goebeler M, Wendtner CM, Bahlo J, Fischer K, Bentz M, Emmerich B, Döhner H, Hallek M, Stilgenbauer S. Early, risk-adapted treatment with fludarabine in Binet stage A chronic lymphocytic leukemia patients: results of the CLL1 trial of the German CLL study group. Leukemia. 2017 Aug 14. doi: 10.1038/leu.2017.246. [Epub ahead of print]

Göbel M, Eisele L, Möllmann M, Hüttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Döhner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Dührsen U, Dürig J. Progranulin is a novel independent predictor of disease progression and overall survival in chronic lymphocytic leukemia. PLoS One. 2013 Aug 23;8(8):e72107. doi: 10.1371/journal.pone.0072107. eCollection 2013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Döhner H, Jäger U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.


Responsible Party:	German CLL Study Group
ClinicalTrials.gov Identifier:	NCT00262782 History of Changes
Other Study ID Numbers:	CLL1 EU-20548 GCLLSG-138 MEDAC-GCLLSG-CLL1
First Submitted:	December 6, 2005
First Posted:	December 7, 2005
Last Update Posted:	September 13, 2017
Last Verified:	September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by German CLL Study Group:


B-cell chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:


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	Fludarabine phosphate Vidarabine Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents

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