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

Sponsor
Seoul National University Hospital
Study ID
NCT03558607
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Secondary Acute Myelogenous Leukemia Evolving From Myeloproliferative Disorder

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Induction chemotherapy include combination of cytarabine (200mg/m2) and idarubicin (12mg/m2). Both 7+3 and 5+2 regimen is allowed according to age and performance status (PS) as follows; * If Age \< 55 years and ECOG PS \< 2 : 7+3 regimen * If Age ≥ 55 years or ECOG PS = 2 : 5+2 regimen Ruxolitinib is administered for 14 days during induction/consolidation phase. After complete remission after induction, ruxolitinib is administered for the first 14 days during consolidation chemotherapy. Maximum 3 cycles of consolidation is recommended. In case of allogeneic stem cell transplantation (alloSCT), ruxolitinib is discontinued at the time of transplantation. After completion of consolidation, 2 years of ruxolitinib maintenance is planned. The follow-up period is from the time of enrollment until 24 months.

Study Details

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

Key Dates

Start date
May 17, 2018
Status verified
Mar 2020
Primary completion
Apr 30, 2022
Completion
Aug 31, 2024

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm

Primary Outcome Measure

complete remission rate [ Time Frame: After 12 months from induction chemotherapy ]

Central Contacts