Study Summary
This trial will compare the different tyrosine kinase inhibitors, with and without ruxolitinib, to see how well they work in treating patients with chronic myeloid leukemia.
Eligible Conditions
- Chronic Myelogenous Leukemia (CML)
Treatment Effectiveness
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 5 years
At 12 months
Rate of molecular response 4.5 (MR4.5)
Year 5
Progression-free survival
Year 5
Overall survival
Up to 12 months
MR4.5 attainment and failure
Molecular rate 4.0 (MR 4.0) attainment and failure
Up to 5 years
BCR-ABL/BCR analysis
Drug compliance
Incidence of adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Arm I (bosutinib, dasatinib, nilotinib, imatinib)
1 of 4
Arm I (dasatinib, nilotinib)
1 of 4
Arm II (ruxolitinib phosphate, dasatinib, nilotinib)
1 of 4
Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)
1 of 4
Active Control
Experimental Treatment
84 Total Participants · 4 Treatment Groups
Primary Treatment: Ruxolitinib Phosphate · No Placebo Group · Phase 2
Arm II (ruxolitinib phosphate, dasatinib, nilotinib)Experimental Group · 7 Interventions: Dasatinib, Nilotinib Hydrochloride Monohydrate, Ruxolitinib Phosphate, Bosutinib, Laboratory Biomarker Analysis, Nilotinib, Ruxolitinib · Intervention Types: Drug, Drug, Drug, Drug, Other, Drug, Drug
Arm II (ruxolitinib phosphate, dasatinib, nilotinib, imatinib)Experimental Group · 5 Interventions: Dasatinib, Laboratory Biomarker Analysis, Nilotinib, Ruxolitinib, Imatinib · Intervention Types: Drug, Other, Drug, Drug, Drug
Arm I (bosutinib, dasatinib, nilotinib, imatinib)ActiveComparator Group · 5 Interventions: Dasatinib, Bosutinib, Laboratory Biomarker Analysis, Nilotinib, Imatinib · Intervention Types: Drug, Drug, Other, Drug, Drug
Arm I (dasatinib, nilotinib)ActiveComparator Group · 5 Interventions: Dasatinib, Nilotinib Hydrochloride Monohydrate, Bosutinib, Laboratory Biomarker Analysis, Nilotinib · Intervention Types: Drug, Drug, Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Ruxolitinib
FDA approved
Bosutinib
FDA approved
Nilotinib
FDA approved
Ruxolitinib
FDA approved
Imatinib
2011
Completed Phase 3
~3510
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
386 Previous Clinical Trials
261,569 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,129,030 Total Patients Enrolled
Kendra L SweetPrincipal InvestigatorSouthwest Oncology Group
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients must have detectable BCR-ABL transcripts measured by reverse transcriptase (RT)-PCR at a clinical laboratory improvement act (CLIA)-approved laboratory and reported on the international scale (IS) with a value of > 0.
You must have complete history and physical examination within 28 days prior to randomization.
You have a platelet count of at least 100,000/mm^3 (100.
You have an absolute neutrophil count (ANC) > 1,000/mm^3 (1.
References
- Zhao, Helong, and Michael Deininger. 2021. “Eradicating Residual Chronic Myeloid Leukaemia: Basic Research Lost in Translation”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(21)00001-6.
- Zhao H, Deininger M. Eradicating residual chronic myeloid leukaemia: basic research lost in translation. Lancet Haematol. 2021 Feb;8(2):e101-e104. doi: 10.1016/S2352-3026(21)00001-6. No abstract available.
- 2018. "Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03654768.
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Conditions
Cancer Related
Treatments