Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01661881|
Recruitment Status : Active, not recruiting
First Posted : August 10, 2012
Results First Posted : January 12, 2017
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Rituximab Drug: Bendamustine Drug: Cytarabine||Phase 2|
This was a PII single-arm design to determine whether the regimen looked promising for further study.
• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.
- To assess safety.
- To estimate the rate of complete remission (CR), unconfirmed CR (CRu), partial remission (PR), stable disease (SD) and progressive disease (PD).
- To estimate the rate of successful stem cell mobilization after RB/RC in responding patients.
- To estimate the proportion of patients who can successfully complete the regimen and proceed to autologous stem cell transplantation (ASCT).
- To estimate the rate of neutrophil and platelet engraftment after ASCT.
- To estimate the CR/CRu and PR rate for patients with blastoid variant MCL.
- To estimate the rate of minimal residual disease (MRD)-negativity at treatment completion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||August 16, 2012|
|Actual Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||March 2025|
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
Other Name: Rituxan
Other Name: Treanda
Other Name: Depocyt
- Complete Remission (CR) Rate After 6 Cycles [ Time Frame: Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days. ]The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.
- 1 Year Progression-Free Survival [ Time Frame: Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months. ]1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).
- Autologous Stem Cell Transplant (ASCT) Rate [ Time Frame: All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction. ]ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)
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): NCT01661881
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02113|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Philippe Armand, MD, PhD||Dana-Farber Cancer Institute|