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NCT02443077 · ClinicalTrials.gov registry record · Phase 3
Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Phase 3 study of Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT02443077: Active Phase 3 study of Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type, sponsored by National Cancer Institute (NCI).
NCT02443077 is a Phase 3 study of Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 94 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02443077, a Phase 3 study of Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
Primary Outcome
Will be assessed using the Lugano classification.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cytarabine
- DRUG Carmustine
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- PROCEDURE Autologous Bone Marrow Transplantation
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
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- City of Hope Comprehensive Cancer Center - Duarte
- UC San Diego Moores Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Cedars Sinai Medical Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Parnassus - San Francisco
Arizona
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2016-10-12 |
| Est. Completion | 2026-12-23 |
| Phase | Phase 3 |
What the registry record for NCT02443077 still lists
NCT02443077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02443077 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02443077 about?
NCT02443077 is a clinical study titled "Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma". This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refract...
What is the current status of trial NCT02443077?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 94 participants. The study started on 2016-10-12. Estimated completion is 2026-12-23.
What conditions does trial NCT02443077 study?
This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type.
What interventions are being tested in trial NCT02443077?
The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Carmustine (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Autologous Bone Marrow Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT02443077?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02443077 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02443077's enrollment target sits among peer trials
94 1720th of 2000 higher than 279 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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