Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-03-01 @ 9:45 AM
Study NCT ID:
NCT03654768
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2018-08-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients With Molecular Evidence of Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib phosphate (ruxolitinib) plus a tyrosine-kinase inhibitor (TKI) (bosutinib, dasatinib, imatinib or nilotinib) versus a TKI alone, based on local polymerase chain reaction (PCR) testing to measure BCR-ABL transcripts in chronic phase chronic myelogenous leukemia (CML) patients with molecular evidence of disease.
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities of each regimen in this patient population.
II. To estimate progression free survival and overall survival of each regimen in this patient population.
ADDITIONAL OBJECTIVES:
I. To describe patterns of MR4.5 and molecular response 4.0 (MR4.0) attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population.
II. To evaluate drug compliance based on patient reported drug intake calendars in this patient population.
III. To describe the kinetics of response in this patient population (as measured by quantitative BCR-ABL/BCR ratio) in both arms over the 3, 6, 9, and 12-month time points.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive bosutinib orally (PO) daily or dasatinib PO daily or nilotinib PO twice daily (BID) or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually up to 5 years.
I. To compare the rate of molecular response 4.5 (MR4.5) after 12 months of combination therapy with ruxolitinib phosphate (ruxolitinib) plus a tyrosine-kinase inhibitor (TKI) (bosutinib, dasatinib, imatinib or nilotinib) versus a TKI alone, based on local polymerase chain reaction (PCR) testing to measure BCR-ABL transcripts in chronic phase chronic myelogenous leukemia (CML) patients with molecular evidence of disease.
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of toxicities of each regimen in this patient population.
II. To estimate progression free survival and overall survival of each regimen in this patient population.
ADDITIONAL OBJECTIVES:
I. To describe patterns of MR4.5 and molecular response 4.0 (MR4.0) attainment and failure over the 3, 6, 9, and 12-month time points of each regimen in this patient population.
II. To evaluate drug compliance based on patient reported drug intake calendars in this patient population.
III. To describe the kinetics of response in this patient population (as measured by quantitative BCR-ABL/BCR ratio) in both arms over the 3, 6, 9, and 12-month time points.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive bosutinib orally (PO) daily or dasatinib PO daily or nilotinib PO twice daily (BID) or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ruxolitinib phosphate PO BID on days 1-90, and bosutinib PO daily or dasatinib PO daily or nilotinib PO BID or imatinib PO daily on days 1-90. Treatment repeats every 90 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually up to 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-02066 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| S1712 | OTHER | SWOG | View | |
| S1712 | OTHER | CTEP | View | |
| U10CA180888 | NIH | None | https://reporter.nih.gov/quic… | View |