Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03610971
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase
  • Chronic Phase Chronic Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
  • BCR-ABL Tyrosine Kinase Inhibitor (TKI) — DRUG
    The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.

Study Details

The purpose of this study is to determine if adding Ruxolitinib to a Tyrone Kinase Inhibitor (TKI), prior to a second attempt at stopping a TKI will lead to prolonged treatment free remission (TFR).

Key Dates

Start date
Nov 19, 2019
Status verified
Mar 2026
Primary completion
Sep 25, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy + Remission Phase
    Combination therapy followed by treatment free remission (TFR) phase. Combination Therapy: Ruxolitinib plus BCR-ABL Tyrosine Kinase Inhibitors (TKIs). All eligible patients will begin ruxolitinib in combination with their BCR-ABL TKI on cycle 1 day 1 of the combination phase. For cycle 2 and beyond, if day 1 of a cycle is delayed, day 1 procedures should be repeated if out of the specified window and day 1 of the cycle is considered the day study drug is restarted. They will continue combination therapy for a total of 12 cycles. Each cycle will be approximately 28 days. At the end of 12 cycles ruxolitinib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, participants will discontinue their BCR-ABL TKI and be monitored off treatment.

Primary Outcome Measure

12 Month Treatment Free Remission (TFR) [ Time Frame: 12 months post 12 cycles of treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Emory -Winship Cancer InstituteAtlantaGeorgia30322-
Memorial Sloan Kettering - BergenMontvaleNew Jersey07645-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
David H. Koch Center for Cancer Care at Memorial Sloan KetteringNew YorkNew York10021-
Duke University HospitalDurhamNorth Carolina27710-
Oregon Health & Science UniversityPortlandOregon97239-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLEmory -Winship Cancer Institute· Atlanta, GAMemorial Sloan Kettering - Bergen· Montvale, NJRoswell Park Comprehensive Cancer Center· Buffalo, NYDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering· New York, NYDuke University Hospital· Durham, NC

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