Health Condition 1: C92A- Acute myeloid leukemia with multilineage dysplasia
Conditions
Interventions
Intervention1: Oral Azacytidine and Oral Pomalidomide: Name of the first drug- Oral Azacytidine
Dose- 300 mg
Frequency - Once in a day for 14 days.
The dose can be reduced to 200 mg based upon the tox
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 yrs. 2. Immunophenotypically confirmed diagnosis of Acute myeloid leukaemia 3. Patients with secondary AML progressed from antecedent myelodysplasia are also eligible. 4. In complete remission (CR or CRi) hematological recovery after induction therapy (maximum two courses of induction therapy are allowed). Absolute neutrophil count shall be greater than equal to 1000 per ul and Platelet count greater than equal to 75000 per ul. Patients who have received consolidation therapy (any number of cycles between 0 and 3) can be enrolled in the study. 5. Absence of circulating blasts (bone marrow should contain less than 5% blasts, Auer rods should be absent, extramedullary leukaemia should be absent). 6. ECOG PS less than equal to 2. 7. Patients who tolerated cycle 1 oral azacytidine without any grade 3, 4 haematological toxicities as per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). 8. Patient must have provided written and informed consent for participation. 9. For females of childbearing potential following to be followed Females should be willing and able to comply with the use of contraception for at least 4 weeks before starting Pomalidomide treatment and 4 weeks after stopping Pomalidomide treatment. 10. For Men - must agree to use a latex condom during any sexual contact with women of childbearing potential while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy.
Exclusion criteria
Exclusion criteria: 1.Planned allogeneic hematopoietic cell transplantation 2. Blast crisis of chronic myeloid leukaemia 3. AML-FAB type M3 or AML with cytogenetic abnormality t (15;17) 4. Treatment with azacytidine with or without venetoclax as induction therapy 5.Subject has clinically significant cardiac disease, including: a. Myocardial Infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III and IV. b. Cardiac Arrhythmia (NCI CTCAE Version 5 Grade greater than equal to 2) or clinically significant ECG abnormalities. 6. LVEF greater than 50 percent. 7. Impaired hepatic or renal function as defined by: a. ALT and/or AST greater than 3 x upper limit of normal b. Bilirubin greater than 3 x upper limit of normal 8. Calculated creatinine clearance of less than 50 ml per min (Cockroft-Gault formula) 9. Pre-existing baseline greater than grade 1 peripheral neuropathy 10. Subject has contraindications to required prophylaxis (i.e. Low Molecular Weight Heparins) for deep vein thrombosis and pulmonary embolism. 11. Gastrointestinal disease that may significantly alter the absorption of oral drugs. 12. Active serious infection not controlled by oral or intravenous antibiotics one week before participation. 13. Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose at which 2 out of 6 patients develop dose limiting toxicity.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Safety & toxicity of the oral azacytidine & pomalidomide combination as assessed by the frequency of grade 3 /4 toxicities as per the NCI CTCAE version5.Timepoint: 28 days;2. Relapse-free survival (RFS).Timepoint: Time between the date of enrollment in the study to relapse, death, or last follow-up.;3.Overall survivalTimepoint: Time between the date of enrollment in the study to the date of death irrespective of the cause of death or last follow-up.;4.Minimal residual disease (MRD) status.Timepoint: 6 months & 1 year from the start of maintenance. | — |
Countries
India
Contacts
Public ContactDr Manju Sengar
Tata Memorial Hospital
Outcome results
None listed