Status:
TERMINATED
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
Lead Sponsor:
Marker Therapeutics, Inc.
Conditions:
Acute Myeloid Leukemia
Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose ad...
Detailed 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. Potenti...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04511130
Start Date
October 14 2020
End Date
March 1 2024
Last Update
October 30 2025
Active Locations (18)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Moores Cancer Center at University of Californa San Diego
La Jolla, California, United States, 92093
4
UCLA Department of Medicine
Los Angeles, California, United States, 90095