A phase II study to evaluate the role of short-course Pomalidomide in maintaining treatment-free remission post tyrosine-kinase inhibitor (TKI) discontinuation in adult patients with chronic myeloid leukemia-chronic phase (CML-CP). - REFLECT CM

TRAC TMC Research Administrative Council0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•1. Age more than or equal to 18years.
•2. CML Chronic phase.
•3. Duration of all TKI more than or equal to 3 yrs.
•5. BCR-ABL transcript identified as e13a2 or e14a2.
•6. Patients willing for regular follow up.
•7. Following laboratory values at the time of enrolment to the intervention phase:
•8. Women of reproductive age are using effective contraception, are not pregnant and agree
•not to become pregnant during participation in the trial. Men agree not to father a child while
•on Pomalidomide and till 4 weeks after stopping Pomalidomide

•1.Patients who had warning response or failure with TKI at 6 months or beyond the initiation
•of TKI, as per the ELN 2013 guidelines .
•2. Patients with past history of coronary artery disease, CVA, or thrombotic tendencies.
•3. Uncontrolled Diabetes mellitus.
•4. Non-compliance to TKI for more than 1month at any time point.
•5.Subject has a history of malignancy within 3 years before the date of enrolment (exceptions
•are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
•malignancy that in the opinion of the investigator, is considered cured with minimal risk of
•recurrence within 3 years).
•6. Intolerance or allergy to Aspirin.

发起方

TRAC TMC Research Administrative Council