Ruxolitinib with cytarabine in secondary acute myelogenous leukemia evolving from myeloproliferative neoplasms

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0003209
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

A. Cytologically confirmed AML following MPN
B. Age 18 years or older
C. ECOG performance status 2 or better
D. Adequate physical condition that could tolerate cytotoxic induction chemotherapy judged by investigator:
Serum creatinine = 2.5 mg/dl
·ALT (SGOT) and/or AST (SGPT) equal to or than 1.5 x upper limit of normal
E. No other chemotherapy within 2 weeks except hydroxyurea
F. Life expectancy of = 3 months
G. 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
H. Male should agree to the barrier method during the study period and up to four weeks af-ter the end of the study
I. Signed and dated informed consent of document

Exclusion Criteria

A. uncontrolled infection
B. Pregnancy or breast feeding
C. Pregnant or child-bearing women without will of contraception
D. Patients who received other chemotherapy within 2 weeks of the study enrollment
E. No informed consent
F. patient with acute promyelocytic leukemia
G. Patients participating in other clinical studies at the time of registration
H. prior hypersensitiivty to ruxolitinib
I. Other severe acute or chronic medical or psychiatric condition
J. Prior treatment with ruxolitinib

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete remission (CR) plus CR with incomplete recovery (CRi)

Secondary Outcome Measures

Name	Time	Method
Overall survival/Progression-free survival rate;Classification of adverse reactions determined based on CTCAE version 4.03 and frequency of occurrence by severity are presented.