Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: Prescribing conventional chemotherapy while with holding allo-SCT

• Registration Number: NCT03902769
• Lead Sponsor: Rambam Health Care Campus

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08
• Study Start: 2019-04-15
• Primary Completion: 2021-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• AML diagnosis,
• treated with 3+7 Induction chemotherapy
• Intermediate/standard risk AML

Exclusion Criteria

• Diagnosed of APL
• high risk molecular/cytogenetic score

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard post induction therapy	Prescribing conventional chemotherapy while with holding allo-SCT	For slow responding AML patients, post induction therapy will be provided according to treating physician discretion
No allogeneic SCT	Prescribing conventional chemotherapy while with holding allo-SCT	For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan

Primary Outcome Measures

Name	Time	Method
Event free survival	Two years

Secondary Outcome Measures

Name	Time	Method
Overall survivial	two years