Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Cancer and Leukemia Group B

ClinicalTrials.gov Identifier:

NCT00003248

First received: November 1, 1999

Last updated: March 22, 2011

Last verified: March 2011

History of Changes

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Study Status:	This study has been completed.
Study Completion Date:	June 2010
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Publications:

Woyach JA, Ruppert AS, Heerema NA, et al.: Treatment with fludarabine and rituximab produces extended overall survival (OS) and progression-free survival (PFS) in chronic lymphocytic leukemia (CLL) without increased risk of second malignancy: long-term follow up of CALGB study 9712. [Abstract] Blood 114 (22): A-539, 2009.

Byrd JC, Gribben JG, Peterson BL, Grever MR, Lozanski G, Lucas DM, Lampson B, Larson RA, Caligiuri MA, Heerema NA. Select high-risk genetic features predict earlier progression following chemoimmunotherapy with fludarabine and rituximab in chronic lymphocytic leukemia: justification for risk-adapted therapy. J Clin Oncol. 2006 Jan 20;24(3):437-43. Epub 2005 Dec 12.

Byrd JC, Peterson BL, Morrison VA, Park K, Jacobson R, Hoke E, Vardiman JW, Rai K, Schiffer CA, Larson RA. Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood. 2003 Jan 1;101(1):6-14. Epub 2002 Jul 05.

Morrison VA, Byrd JC, Peterson BL, et al.: Adding Rituximab to Fludarabine therapy for patients with untreated chronic lymphocytic leukemia (CLL) does not Increase the risk of infection: Cancer and Leukemia Group B (CALGB) study 9712. [Abstract] Blood 102 (11 Pt 1): A-1606, 2003.

Byrd JC, Peterson BL, Park K, et al.: Concurrent Rituximab and Fludarabine has a higher complete response rate than sequential treatment in untreated chronic lymphocytic leukemia (CLL) patients: results from CALGB 9712. [Abstract] Blood 98 (11 Pt 1): A-3212, 2001.

Byrd JC, Peterson B, Park K, et al.: Rituximab added to Fludarabine improves response in previously untreated chronic lymphocytic leukemia: preliminary results from CALGB 9712. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1116, 2001.

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