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NCT02728531 · ClinicalTrials.gov registry record · Phase 1
Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02728531: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02728531 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02728531, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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
Primary Outcome
-Stem cell mobilization success is defined as a yield of ≥ 2 x 106 CD34+ stem cells/kg with a maximum of 5 courses of apheresis.
Interventions
- DRUG Rituximab
- DRUG Cytarabine
- PROCEDURE Leukapheresis
- DRUG Bendamustine
- DRUG Pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2016-04-18 |
| Est. Completion | 2023-08-16 |
| Phase | Phase 1 |
What the finished NCT02728531 record still lists
NCT02728531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT02728531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02728531 about?
NCT02728531 is a clinical study titled "Bendamustine and Rituximab Alternating With Cytarabine and Rituximab for Untreated Mantle Cell Lymphoma". 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 s...
What is the current status of trial NCT02728531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2016-04-18. Estimated completion is 2023-08-16.
What interventions are being tested in trial NCT02728531?
The interventions under investigation include: Rituximab (DRUG), Cytarabine (DRUG), Leukapheresis (PROCEDURE), Bendamustine (DRUG), Pegfilgrastim (DRUG).
Who is sponsoring clinical trial NCT02728531?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02728531's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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