Overview
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 85-130 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 85-130 - 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
Principal investigator
Eligibility criteria
Inclusion Criteria
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First allogeneic HSCT, in ≤ CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
- Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or
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Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
- First relapse (MRD+ or frank relapse) post-HSCT
- Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
- Safety Lead-in defined as patients who fit all the criteria for Group 2 only
- Are ≥18 years of age
- Karnofsky/Lansky score of ≥60
- Life expectancy ≥12 weeks
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Adequate blood, liver, and renal function
- Blood: Hemoglobin ≥7.0 g/dL (can be transfused)
- Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal
- Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min
7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.
8. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit
Exclusion Criteria
- Clinically significant or severely symptomatic intercurrent infection
- Pregnant or lactating
- For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
- For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
- Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401
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