Role of hypomethylating agents to improve survival outcomes in patients with high-risk acute myeloid leukemia who underwent allogeneic stem cell transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004821

Enrollment

Registered

2020-03-12

Start date

2020-04-01

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In the prophylactic hypomethylating group, patients receive of azacitidine 32mg/m2 for 5 days (subcutaneous or intravenous) every 4 weeks, up to 6 cycles. In the control group, examination for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation (High-risk AML: patients with adverse risk group according to the 2017 ELN risk stratification by genetics, patients with primary refractory disease, and patients with first relapse after achieving complete remission [CR].) ** Adverse risk category of 2017 ELN risk stratification by genetics (2017 ELN recommendation) t(6;9)(p23;q34.1); DEK-NUP214 t(v;11q23.3); KMT2A rearranged t(9;22)(q34.1;q11.2); BCR-ABL1 inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM(EVI1) -5 or del(5q); -7; -17/abn(17p) Complex karyotype, monosomal karyotype Wild-type NPM1 and FLT-ITDhigh Mutated RUNX1 Mutated ASXL1 Mutated TP53 2. Bone marrow blast should be less than 5%, and absolute neutrophil count and platelet count should be over 1,000/uL and 50,000/uL, respectively. 3. Men and women =19, < 70 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2. 5. Patients who achieved CR after allogeneic stem cell transplantation 1) Complete remission (CR) - Bone marrow blasts < 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - Absolute neutrophil count > 1.0 x 109/L (1000/uL) - Platelet count > 80 x 109/L (80,000/uL) - Independence of red cell transfusions 2) CR with incomplete recovery - All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/uL]) or thrombocytopenia (< 80 x 109/L [80,000/uL]) 6. Patients with adequate liver, kidney, heart function. 7. Patients who can evaluate chimerism every 4 weeks 8. Woman of childbearing potential who are sexually active must have negative urine hCG test prior to the treatment. Participants must use 2 methods including at least 1 highly effective method of contraception during treatment period and for 4 weeks after the treatment. 9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. 10. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Exclusion criteria

Exclusion criteria: 1. Treatment history with hypomethylating agent 2. Prior malignancy (or any other malignancy that requires active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid carcinoma or other cancer from which the subject has been disease free for over 5 years or which will not limit survival to less than 5 years. 3. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. 4. Known history of infection with HIV or any uncontrolled active systemic infection (e.g. Bacterial, vial or fungal). 5. History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) within 6 months before the treatment. 6. Total bilirubin > 3 x ULN, or AST, ALT > 3 x ULN 7. Creatinine > 2 x ULN 8. Breastfeeding or pregnant. 9. Concurrent participation in another therapeutic clinical trial.

Design outcomes

Primary

Measure	Time frame
Relapse free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactDong Won Baek

Kyungpook National University Hospital

Outcome results