Trials / Completed
CompletedNCT02728531
Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
A Pilot Study of Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Given the established role of high dose cytarabine (HiDAC) combined with rituximab, along with recent data showing the encouraging efficacy of bendamustine, the investigators seek to integrate the synergistic effects of these medicines in alternating cycles as induction therapy prior to autologous stem cell transplant (ASCT). Based on prior experience with bendamustine and rituximab (BR) based induction therapy, the investigators seek to evaluate the efficacy and safety of stem cell mobilization in this pilot study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine | |
| DRUG | Rituximab | |
| DRUG | Cytarabine | |
| DRUG | Pegfilgrastim | |
| PROCEDURE | Leukapheresis | |
| DRUG | Filgrastim | |
| PROCEDURE | Autologous stem cell transplant |
Timeline
- Start date
- 2016-04-18
- Primary completion
- 2019-01-16
- Completion
- 2023-08-16
- First posted
- 2016-04-05
- Last updated
- 2023-11-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02728531. Inclusion in this directory is not an endorsement.