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NCT01661881 · ClinicalTrials.gov registry record · Phase 2
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma, sponsored by Dana-Farber Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT01661881: Active Phase 2 study of Mantle Cell Lymphoma, sponsored by Dana-Farber Cancer Institute.
NCT01661881 is a Phase 2 study of Mantle Cell Lymphoma that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 23 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01661881, a Phase 2 study of Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Cytarabine
- DRUG Bendamustine
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-08-16 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
What the registry record for NCT01661881 still lists
NCT01661881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT01661881 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01661881 about?
NCT01661881 is a clinical study titled "Rituximab/Bendamustine + Rituximab/Cytarabine for 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 Ritu...
What is the current status of trial NCT01661881?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2012-08-16. Estimated completion is 2030-04.
What conditions does trial NCT01661881 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT01661881?
The interventions under investigation include: Rituximab (DRUG), Cytarabine (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01661881?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01661881 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01661881's enrollment target sits among peer trials
23 79th of 102 higher than 22 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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
-
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
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-
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL
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-
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
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Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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-
Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
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-
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
RECRUITING · Phase 2
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