Fludarabine Phosphate, Rituximab, and Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia That Has Relapsed or Not Responded To Treatment
|ClinicalTrials.gov Identifier: NCT00845104|
Recruitment Status : Withdrawn (No patients enrolled.)
First Posted : February 18, 2009
Last Update Posted : March 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia Refractory Chronic Lymphocytic Leukemia||Drug: fludarabine phosphate Biological: rituximab Biological: bevacizumab Other: laboratory biomarker analysis Other: flow cytometry Genetic: polymerase chain reaction Genetic: fluorescence in situ hybridization||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||January 2009|
Experimental: Arm I
See Detailed Description
Drug: fludarabine phosphate
Other Names:Biological: rituximab
Other Names:Biological: bevacizumab
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: flow cytometry
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCRGenetic: fluorescence in situ hybridization
Other Name: fluorescence in situ hybridization (FISH)
- Progression-free survival [ Time Frame: At 2 years ]
- Response (complete, partial, or nodular partial response, progressive disease, stable disease, or minimal residual disease) [ Time Frame: At 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845104
|Principal Investigator:||John Pagel||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|