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

Rambam Health Care Campus

Status: Unknown

Conditions: Acute Myeloid Leukemia

Treatments: Procedure: Prescribing conventional chemotherapy while with holding allo-SCT

Study type: Interventional

Funder types: Other

Identifiers

NCT03902769

RMB-250-18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Diagnosed of APL
• high risk molecular/cytogenetic score

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

No allogeneic SCT

Experimental group

Description:

For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan

Treatment:

Procedure: Prescribing conventional chemotherapy while with holding allo-SCT

Standard post induction therapy

Active Comparator group

Description:

For slow responding AML patients, post induction therapy will be provided according to treating physician discretion

Treatment:

Procedure: Prescribing conventional chemotherapy while with holding allo-SCT