Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 69 |
| Updated: | 9/8/2018 |
| Start Date: | August 2012 |
| End Date: | March 2019 |
A Phase II Study of Rituximab/Bendamustine Followed by Rituximab/Cytarabine for Untreated Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to
improve upon standard of care in newly diagnosed, untreated MCL patients who were
transplant-eligible using drugs already established as active in MCL. The combination of
Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize
pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with
tolerable toxicity.
improve upon standard of care in newly diagnosed, untreated MCL patients who were
transplant-eligible using drugs already established as active in MCL. The combination of
Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize
pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with
tolerable toxicity.
This was a PII single-arm design to determine whether the regimen looked promising for
further study.
Primary Objective
• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and
Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.
Secondary Objectives
- 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.
further study.
Primary Objective
• To evaluate the efficacy of an alternating regimen of Rituximab-Bendamustine and
Rituximab-Cytarabine (RB/RC) using the CR/Cru rate.
Secondary Objectives
- 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.
Inclusion Criteria:
- Mandatory pathologic review of the diagnostic specimen(s) at Brigham and Women's
Hospital or Massachusetts General Hospital
- Measurable disease
- Candidate for ASCT
Exclusion Criteria:
- Prior anti-lymphoma therapy
- Pregnant or breastfeeding
- Hypersensitivity to rituximab
- Uncontrolled intercurrent illness
- Receiving other study agents
- HIV positive on combination antiretroviral therapy
We found this trial at
3
sites
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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