Outcome of Patients With CBF and/or NPM1-mutated AML in First Molecular Relapse. (MOLAM)

University Hospital, Angers

Status: Unknown

Conditions: Acute Myeloid Leukemia

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04931992

202100042

Details and patient eligibility

About

Despite good initial response, some patients with core binding factor and/or NPM1-mutated AML eventually relapse. Some of these patients can be identified earlier on, before overt cytological relapse, when followed for minimal residual disease. The outcome of patients treated when molecular relapse is confirmed, before overt cytological relapse, is not well known. This multi-center retrospective will therefore study the outcome of these patients and try to specify the role of allogeneic stem cell transplantation in this setting.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 and 61 years
• Diagnosis between 2010 and 2019
• Core binding factor and/or NPM1 acute myeloid leukemia
• First complete remission after induction therapy
• Measurable residual disease measurement after end of consolidation therapy

Exclusion criteria

• Acute promyelocytic leukemia
• Allogeneic stem cell transplantation in CR1

Trial design

100 participants in 3 patient groups

Molecular relapse

Description:

Confirmed molecular relapse, without overt cytological relapse

Treatment:

Other: No intervention

Cytological relapse

Description:

Overt cytological relapse, without prior molecular relapse

Treatment:

Other: No intervention

Persistent responders

Description:

No molecular or cytological relapse during follow-up

Treatment:

Other: No intervention