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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04115631
The ClinicalTrials.gov registry entry for NCT04115631 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (256% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.