Ruxolitinib Phosphate for Chronic Myelogenous Leukemia (CML)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Myelogenous Leukemia (CML)Ruxolitinib Phosphate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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.