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NCT04115631 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma and Liver Lymphoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT04115631: Active Phase 2 study of Mantle Cell Lymphoma and Liver Lymphoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04115631 is a Phase 2 study of Mantle Cell Lymphoma and Liver Lymphoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 360 participants, above the 101-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (256% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115631, a Phase 2 study of Mantle Cell Lymphoma and Liver Lymphoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.
Primary Outcome
MRD status is defined as positive, negative, or indeterminate as measured from PB specimens following completion of treatment. Measures of frequencies and proportion, and location and dispersion will be used to describe categorical, and continuous variables respectively; 90% confidence intervals around these estimates will be computed. Kaplan-Meier method will be used to describe time-to-event endpoints and log-rank test to assess difference in time-to-event endpoints by levels of a categorical
Conditions Studied
Interventions
- BIOLOGICAL Rituximab
- DRUG Cytarabine
- DRUG Acalabrutinib
- DRUG Bendamustine
- DRUG Bendamustine Hydrochloride
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Kaiser Permanente-Anaheim - Anaheim
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente-Fontana - Fontana
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04115631 still lists
NCT04115631 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 101-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (256% higher).
The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT04115631 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04115631 about?
NCT04115631 is a clinical study titled "A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma". This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work...
What is the current status of trial NCT04115631?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2019-12-13. Estimated completion is 2026-12-31.
What conditions does trial NCT04115631 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Liver Lymphoma.
What interventions are being tested in trial NCT04115631?
The interventions under investigation include: Rituximab (BIOLOGICAL), Cytarabine (DRUG), Acalabrutinib (DRUG), Bendamustine (DRUG), Bendamustine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04115631?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04115631 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. 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 NCT04115631's enrollment target sits among peer trials
360 9th of 102 higher than 94 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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