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NCT03516279 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
A Phase 2 study of Minimal Residual Disease and Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT03516279: Active Phase 2 study of Minimal Residual Disease and Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by ECOG-ACRIN Cancer Research Group.
NCT03516279 is a Phase 2 study of Minimal Residual Disease and Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 40 participants, below the 12,577-participant average among 8 other Minimal Residual Disease trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03516279, a Phase 2 study of Minimal Residual Disease and Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic myeloid leukemia.
Primary Outcome
Will be reported with exact confidence intervals. The binomial test will be used to test the null hypothesis that this proportion is 0.2 with the alternative hypothesis being that this proportion is greater than 0.2.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Dasatinib
- DRUG Nilotinib
- DRUG Imatinib Mesylate
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Contra Costa Regional Medical Center - Martinez
- Mercy Cancer Center - Merced
- Mercy Cancer Center - Rocklin - Rocklin
- Mercy Cancer Center - Sacramento - Sacramento
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
- BASS Medical Group - Lennon - Walnut Creek
- Woodland Memorial Hospital - Woodland
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- CARTI Cancer Center - Little Rock
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Cancer Center at Saint Joseph's - Phoenix
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2031-08-31 |
| Phase | Phase 2 |
What the registry record for NCT03516279 still lists
NCT03516279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 12,577-participant average among 8 other Minimal Residual Disease trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Minimal Residual Disease appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03516279 names 20 study sites across 5 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT03516279 about?
NCT03516279 is a clinical study titled "Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease". This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Monoclonal antibodies, ...
What is the current status of trial NCT03516279?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2019-06-26. Estimated completion is 2031-08-31.
What conditions does trial NCT03516279 study?
This clinical trial studies the following conditions: Minimal Residual Disease, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT03516279?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Dasatinib (DRUG), Nilotinib (DRUG), Imatinib Mesylate (DRUG).
Who is sponsoring clinical trial NCT03516279?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03516279 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03516279's enrollment target sits among peer trials
40 5th of 8 higher than 4 of 8 other Minimal Residual Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Minimal Residual Disease 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.
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