Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

Summary

Participation Requirements

Description

This study is in patients aged ?18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML. Potential patients for the study may be screened/enrolled: • Prior to their first allogeneic HSCT. or • Pati...

This study is in patients aged ?18 years old undergoing or having relapsed after their first allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for AML. Potential patients for the study may be screened/enrolled: • Prior to their first allogeneic HSCT. or • Patients experiencing their first relapse post-allogeneic transplant. Patients eligible for the study will be placed into one of two groups: Adjuvant (Group 1): Patients screened prior to their HSCT with CR without minimal residual disease (CRMRD-) at 90 days post transplant will be randomized (1:1) in an unblinded fashion to: MT-401 (Arm A) SOC (Arm B) Active Disease: (Group 2): Patients meeting the following criteria will be assigned to Group 2 and will receive MT 401: Patients who experience relapse (patients with MRD [MRD+] or frank relapse) at or prior to post-transplant Day 90 Patients in Arm B of Group 1 (SOC) who develop relapse (MRD+ or frank relapse) post-HSCT (crossover patients) Patients who do not consent prior to HSCT but are experiencing their first relapse (MRD+ or frank relapse) and have the same donor available for manufacturing

Tracking Information