Health Condition 1: C920- Acute myeloblastic leukemia Health Condition 2: null- They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification excluding APML
Conditions
Interventions
Intervention1: ADE chemotherapy
Ara-c (A) 200 mg/sqm day 1 to day 10 twice daily as intravenous bolus for first induction and 200 mg/sqm/day, day 1 to day 8 twice daily as intravenous bolus for secon
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: 1.They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) excluding APML. 2. They are considered suitable for intensive chemotherapy. 3. They should be under the age of 18 4. They have given written informed consent 5. HepB,HIV,HCV negative.
Exclusion criteria
Exclusion criteria: 1. Age more than 18 years 2. Children with APML 3. Abnormal Renal function test 4. Abnormal liver functions 5. ECOG Performance status >2 6. Pregnancy in case of females 7. Cardiac dysfunction 8. HBsaG/HIV/HCV Seropositive cases 9. Patients not giving consent. 10. They have previously received cytotoxic chemotherapy for AML. 11. They have a concurrent active malignancy 12. The physician and patient consider that intensive therapy is not an appropriate treatment option
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the CR rates between both the regimens in patients with AML aged less than 18 years oldTimepoint: Complete remission (CR) achievement at end of induction chemotherapy . Toxicity, both haematological and non-haematological at the end of each cycle of chemotherapy. Overall survival in both arms at the end of last follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare overall survival, event free survival and toxicity between DA and ADE chemotherapyTimepoint: Death and relapse | — |
Countries
India
Contacts
Public ContactVenkatraman R
Cancer Institute (WIA)
Outcome results
None listed