Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 160
- Primary Endpoint
- Event free survival
Study Overview
Brief Summary
We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).
Detailed Description
Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 61 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •AML diagnosis,
- •treated with 3+7 Induction chemotherapy
- •Intermediate/standard risk AML
Exclusion Criteria
- •Diagnosed of APL
- •high risk molecular/cytogenetic score
Arms & Interventions
No allogeneic SCT
For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan
Intervention: Prescribing conventional chemotherapy while with holding allo-SCT (Procedure)
Standard post induction therapy
For slow responding AML patients, post induction therapy will be provided according to treating physician discretion
Intervention: Prescribing conventional chemotherapy while with holding allo-SCT (Procedure)
Outcomes
Primary Outcomes
Event free survival
Time Frame: Two years
Secondary Outcomes
- Overall survivial(two years)
Investigators
Dr. Yishai Ofran
Director of leukemia Service
Rambam Health Care Campus