Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along with recent data showing the encouraging efficacy of bendamustine, the investigators seek to integrate the synergistic effects of these medicines in alternating cycles as induction therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate the efficacy and safety of stem cell mobilization in this pilot study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Washington University School of Medicine
St Louis, Missouri, United States
Stem cell mobilization success rate
-Stem cell mobilization success is defined as a yield of ≥ 2 x 106 CD34+ stem cells/kg with a maximum of 5 courses of apheresis.
Time frame: Completion of stem cell mobilization (approximately 25 weeks)
Overall response rate
-Response to treatment is guided based upon the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
Time frame: Completion of treatment (approximately 24 weeks)
Pre-transplant complete response rate (CRR)
CRR= * Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. * London Deauville score of 1 and 2 in lymph nodes and extra lymphatic sites is considered to represent complete metabolic response. A London Deauville score 3 in the post treatment PET scan may be considered to represent complete metabolic response especially if it is not higher than the surrounding normal physiologic uptake. * No evidence of FDG avid disease in the bone marrow * No new lesions * If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.
Time frame: Completion of treatment (approximately 24 weeks)
Progression-free survival (PFS)
-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Safety and tolerability of bendamustine and rituximab alternating with cytarabine and rituximab as measured by grades 3 or higher toxicities
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: 30 days following completion of treatment (approximately 29 weeks)
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