Acute Myeloid Leukemia Clinical Trial
— Ara-cOfficial title:
Comparison of Ara-c 12 gm/m2 vs 18 gm/m2 Per Cycle for 3 Cycles Each as Consolidation in AML ; An Open Label Randomized Non-inferiority Study
The study will be conducted in the Department of Medical Oncology and Department of Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in complete remission after induction chemotherapy will be enrolled into the study and will be further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3 cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the relapse free survival and overall survival as well as time to relapse and toxicity /treatment related morbidity.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis - Suitable for HIDAC as consolidation - AML with underlying MDS will be included Exclusion Criteria: - Previous AML chemotherapy [Hydroxyurea - not an exclusion.] - CML-BC - Concurrent active malignancy - HIV infection, Uncontrolled Hepatitis B/C - Patients being considered for upfront PBSCT (before completion of CONSOLIDATION) - Serum Bilirubin > 2 - APML - Delayed recovery of blood counts /persistent active infection > 45 days from start of induction - Patients receiving reinduction with HIDAC - Therapy related AML |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | AIIMS | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse free survival at 1 yr of follow up | 1 year | No | |
Secondary | Toxicity- Haematological and Non -Haematological | The following variables will be compared in the two arms to - -Nadir blood counts,Ara c related fever ,Allergic or skin reactions,Alopecia,Diarrhea ,Stomatitis,Bleeding ,Febrile neutropenia,Infection(fungal /bacterial/viral),Liver related event,ocular toxicity,Neurologic event,Peripheral neuropathy,Cerebral/Cerebellar toxicity,Transfusions,Time to recovery of platelets,Time to recovery of neutrophils,Duration of Hospital stay,Emergency visits,Deaths,Use of growth factors |
at 1 yr | Yes |
Status | Clinical Trial | Phase | |
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