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NCT03654768 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
A Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT03654768: Active Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by SWOG Cancer Research Network.
NCT03654768 is a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 81 participants, above the 68-participant average among 7 other Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03654768, a Phase 2 study of Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.
Primary Outcome
The participants BCR-ABL/BCR ratio must be at least 31,623 times (4.5 logs) smaller than100% IS, i.e., must demonstrate a 4.5-log reduction relative to 100% IS. When reported on the International Scale (IS), this response is equivalent to a value of ≤ 0.0032%. Values are reported as percentages with a higher rate being better then a lower rate.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Ruxolitinib
- DRUG Dasatinib
- DRUG Bosutinib
- DRUG Nilotinib
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
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Providence Queen of The Valley - Napa
- Pacific Central Coast Health Center-San Luis Obispo - San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria - Santa Maria
- Providence Medical Foundation - Santa Rosa - Santa Rosa
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
What the registry record for NCT03654768 still lists
NCT03654768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 68-participant average among 7 other Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03654768 names 20 study sites across 4 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03654768 about?
NCT03654768 is a clinical study titled "Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia". This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to...
What is the current status of trial NCT03654768?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2018-10-24. Estimated completion is 2028-07-01.
What conditions does trial NCT03654768 study?
This clinical trial studies the following conditions: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive.
What interventions are being tested in trial NCT03654768?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ruxolitinib (DRUG), Dasatinib (DRUG), Bosutinib (DRUG), Nilotinib (DRUG).
Who is sponsoring clinical trial NCT03654768?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03654768 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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