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Clinical Trial 19660

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03610971

Phase: Phase II
Principal Investigator: Sweet, Kendra

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Treatment Free Remission After Combination Therapy with Ruxolitinib Plus Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Summary

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).

Objective

Primary Objective: To determine the 1-year treatment free remission rate after 12 cycles of combination therapy with TKIs plus ruxolitinib in subjects who have experienced molecular relapse after prior TKI discontinuation.

Treatments

Therapies

Therapy (NOS)

Medications

AMN107 (Nilotinib); Dasatinib (BMS-354825); Gleevac (Imatinib Mesylate); Imatinib Mesylate (); Nilotinib (); Ponatinib (AP24534); Rituxan (rituximab); STI571 (Imatinib Mesylate); Tasigna (Nilotinib); rituximab ()

Inclusion Criteria

Willing and able to give informed consent

Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.

Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician

Must have met ALL the following criteria prior to first attempt to discontinue their TKI: - Stable molecular response (MR4; 2 years, as documented on at least 4 tests, performed at least 3 months apart.(e.g. If a patient has had >4 PCR tests performed during the two years leading up to their initial TKI discontinuation, any value between 0.01 and 0.05% IS is considered a stable result, however, at least 4 tests must be >Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR-ABL > 0.1% IS after first attempted discontinuation of TKI

After first failed TFR attempt, must have a minimum duration of 1 year on a TKI, and must plan to remain on this same TKI for a minimum of 12 months during the combination treatment phase

Current TKI must be the same as the TKI being taken prior to the initial TFR attempt (e.g., if patient is on imatinib prior to first TFR attempt, they should be on imatinib at time of enrollment on this study)

Eastern Cooperative Oncology Group (ECOG) performance status 0-3

Must have a RQ-PCR for BCR-ABL less than 0.01% IS reported by the trial designated central lab at time of study enrollment

Must adhere to all study contraception guidelines

Exclusion Criteria

History of accelerated or blast phase CML

History of TKI resistance

A second malignancy requiring active treatment

Have previously received treatment with a JAK inhibitor.

Platelet count less than 100 × 10^9/L or an absolute neutrophil count of less than 1 × 10^9/L or Hemoglobin less than 8 g/dL

AST and ALT ≥ 3 times the institutional upper limit of normal (ULN)

Creatinine ≥ 2 times ULN

Total bilirubin ≥ 1.5 times ULN (unless direct bilirubin is within normal limits)

Pregnant or lactating

Unable to comply with lab appointments schedule and patient response outcome assessments

Another investigational drug within 4 weeks of enrollment

Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol

Have undergone a prior allogeneic transplant

Screening 12-lead ECG showing a baseline corrected QT interval >500msec (patients with a pacemaker will still be eligible with QTc>500msec)

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