Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02728531|
Recruitment Status : Active, not recruiting
First Posted : April 5, 2016
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Bendamustine Drug: Rituximab Drug: Cytarabine Drug: Pegfilgrastim Procedure: Leukapheresis Drug: Filgrastim Procedure: Autologous stem cell transplant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||April 18, 2016|
|Actual Primary Completion Date :||January 16, 2019|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Bendamustine, Rituximab, Cytarabine
Other Name: Rituxan
Other Name: Neupogen
Procedure: Autologous stem cell transplant
- Stem cell mobilization success rate [ Time Frame: Completion of stem cell mobilization (approximately 25 weeks) ]-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.
- Overall response rate [ Time Frame: Completion of treatment (approximately 24 weeks) ]-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.
- Pre-transplant complete response rate (CRR) [ Time Frame: Completion of treatment (approximately 24 weeks) ]
- 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.
- Progression-free survival (PFS) [ Time Frame: 5 years ]-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- 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 [ Time Frame: 30 days following completion of treatment (approximately 29 weeks) ]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.
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): NCT02728531
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Brad S Kahl, M.D.||Washington University School of Medicine|