NCT00845104

Fludarabine Phosphate, Rituximab, and Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Relapsed or Not Responded To Treatment

A Phase II Study of Fludarabine (F), Rituxan (R) and Avastin (A) Followed by RA Maintenance in Patients With Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine phosphate together with rituximab and bevacizumab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving fludarabine phosphate together with rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia that has relapsed or not responded to treatment.

Detailed description

PRIMARY OBJECTIVES: I. To estimate PFS at 2 years after FR plus Avastin (A) induction followed by Rituximab plus Avastin (RA) maintenance therapy for relapsed/refractory CLL patients. SECONDARY OBJECTIVES: I. To evaluate response rates after FR-A induction and RA maintenance therapy. II. To eliminate residual disease (documented by flow cytometry and/or PCR) in patients who have achieved a CR after FR-A. III. To estimate the rate of conversion of PR to CR after FR-A. IV. To determine the safety and pharmacokinetics of FR-A and RA maintenance. OUTLINE: INDUCTION THERAPY: Patients receive fludarabine phosphate IV over 20-30 minutes once daily on days 1-5 and rituximab IV once daily on days 4 or 5. Treatment repeats every 35 days for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 8 of course 1, patients also receive bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 9 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response, partial response, or nodular partial response proceed to maintenance therapy. MAINTENANCE THERAPY: Beginning 2 months after completion of induction treatment, patients receive rituximab IV every 3 months and bevacizumab IV over 30 minutes every 3 weeks. Treatment continues for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	fludarabine phosphate	Given IV
BIOLOGICAL	rituximab	Given IV
BIOLOGICAL	bevacizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies
GENETIC	fluorescence in situ hybridization	Correlative studies

Timeline

• Start date: 2009-01-01
• First posted: 2009-02-18
• Last updated: 2015-03-06