Last reviewed · How we verify
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.
Details
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 23 |
| Start date | 2012-08-16 |
| Completion | 2030-04 |
Conditions
- Mantle Cell Lymphoma
Interventions
- Rituximab
- Bendamustine
- Cytarabine
Primary outcomes
- Complete Remission (CR) Rate After 6 Cycles — 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.
Countries
United States