A clinical trial to study efficacy and toxicity of two doses of Ara-c in Acute Myeloid Leukemia , 18 gm/m2 and 12 gm/m2 for 3 cycles each

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2012
INTERVENTION: Intervention1: Ara‐c at 18 gm/m2 X 3 cycles: Arm A ‐ 18 gm/m2 for 3 cycles( 3 gm/m2 BD , d1,3,5) Control Intervention1: Ara‐c at 12 gm/m2 X 3 cycles: Arm B‐ 12 gm/m2 (2 gm/m2 BD D1,3,5) for 3 cycles CONDITION: Acute Myeloid Leukemia PRIMARY OUTCOME: To analyze Relapse free survival‐‐‐‐‐‐Timepoint: at 1 yr of follow up SECONDARY OUTCOME: 2. To analyze Overall survival, Median time to relapse And Toxicity‐ Haematological and Non Haematological in the two arms‐‐‐‐‐‐Timepoint: at 1 yr INCLUSION CRITERIA: there shall be no upper age limit, if performance status permits patients of any age can be enrolled ‐ Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis ‐ Suitable for HIDAC as consolidation
Epistemonikos ID: 3961f52b698edda00725b30de0f5d24898482e97
First added on: Jan 21, 2022