drugset / Trial / NCT01661881
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
Phase 2
Active not recruiting
23 enrolled
Christine Ryan
Beth Israel Deaconess Medical Center · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2012-08-16
- Primary completion
- 2015-02
- Completion
- 2030-04
Outcome
Met primary endpoint
paper 96% of patients achieved a CR/unconfirmed CR after treatment, meeting the primary objective. PMID 26729345 ↗
Publications
- Results Armand P, Redd R, Bsat J, Mayuram S, Giardino A, Fisher DC, LaCasce AS, Jacobson C, Davids MS, Brown JR, Weng L, Wilkins J, Faham M, Freedman AS, Joyce R, Jacobsen ED. A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma. Br J Haematol. 2016 Apr;173(1):89-95. doi: 10.1111/bjh.13929. Epub 2016 Jan 5.
- Results Merryman RW, Edwin N, Redd R, Bsat J, Chase M, LaCasce A, Freedman A, Jacobson C, Fisher D, Ng S, Crombie J, Kim A, Odejide O, Davids MS, Brown JR, Jacene H, Cashen A, Bartlett NL, Mehta-Shah N, Ghobadi A, Kahl B, Joyce R, Armand P, Jacobsen E. Rituximab/bendamustine and rituximab/cytarabine induction therapy for transplant-eligible mantle cell lymphoma. Blood Adv. 2020 Mar 10;4(5):858-867. doi: 10.1182/bloodadvances.2019001355.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 1 g | — |
| Subject | Cytarabine | Small molecule | 1.5 g | — |
| Subject | Cytarabine | Small molecule | 2 g | — |
| Subject | Cytarabine | Small molecule | 3 g | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |