The Role of Ruxolitinib in Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Neoplasm

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial aimed to investigate the therapeutic efficacy of ruxolitinib in combination with cytotoxic chemotherapy for post-myeloproliferative neoplasm secondary acute myeloid leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• Cytologically confirmed AML following MPN

• ECOG performance status 2 or better

• Adequate physical condition that could tolerate cytotoxic induction chemotherapy judged by investigator

• Age 18 years or older

• Adequate cardiac function

• Adequate hepatic, and renal function

• Serum creatinine ≤ 2.5 mg/dl

• ALT (SGOT) and/or AST (SGPT) equal to or than 1.5 x upper limit of normal

• Life expectancy of ≥ 3 months

• Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

• For women of childbearing age, it should be confirmed that they are not pregnant and that they should be contraception during the study period and for up to 4 weeks after the end of the study

• Male should agree to the barrier method during the study period and up to four weeks after the end of the study

Exclusion Criteria:

• Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri

• Pregnancy or breast feeding

• Other severe acute or chronic medical or psychiatric condition

• Prior treatment with ruxolitinib

• Patients who received other chemotherapy within 2 weeks of the study enrollment

• Patients participating in other clinical studies at the time of registration