Acute Myeloid Leukemia Clinical Trial

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

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 administered is 50 x 10^6 cells (flat dosing).

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Full 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

• 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

View Eligibility Criteria

Eligibility Criteria

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 90 days (±10 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT04511130

Recruitment Status:

Recruiting

Sponsor:

Marker Therapeutics, Inc.

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There are 17 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35249, United States More Info
Antonio Di Staci, MD
Contact
205-801-8415
[email protected]
Lindsey Stephens, RN
Contact
205.975.2028
[email protected]
Antonio Di Staci, MD
Principal Investigator
City of Hope National Medical Center
Duarte California, 91010, United States More Info
Shukaib Arslan, MD
Contact
877-467-3411
[email protected]
Shukaib Arslan, MD
Principal Investigator
Moores Cancer Center at University of Californa San Diego
La Jolla California, 92093, United States More Info
Michelle Padilla
Contact
858-822-5223
[email protected]
Divya Koura, MD
Principal Investigator
UCLA Department of Medicine
Los Angeles California, 90095, United States More Info
Vladimir kustanovich
Contact
310-206-5756
[email protected]
Gary Shiller, MD
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06519, United States More Info
Alexandra Dormal
Contact
203-737-4839
[email protected]
Iris Isufi, MD
Principal Investigator
Mayo Clinical Cancer Center-Florida
Jacksonville Florida, 32224, United States More Info
Tammy Bicknese
Contact
507-266-6841
[email protected]
Hemant Murthy, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Maria Urdiales
Contact
813-745-1218
[email protected]
Michelle Burton, RN
Contact
813.745.1537
[email protected]
Nelli Bejanyan, MD
Principal Investigator
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Ashley Trumbull
Contact
404-778-3969
[email protected]
Corey Williams
Contact
404-251-2014
[email protected]
William Blum, MD
Principal Investigator
University of Chicago
Chicago Illinois, 77027, United States More Info
Hongtao Liu, MD
Contact
773-702-0589
[email protected]
Hongtao Liu, MD
Principal Investigator
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States More Info
Margarida Silverman, MD
Contact
319-356-1616
[email protected]
Karen Parrott, RN
Contact
319.353.6347
[email protected]
Margarida Silverman, MD
Principal Investigator
Mayo Clinic Cancer Center-Rochester
Rochester Minnesota, 55905, United States More Info
Mary Glatzmaier
Contact
507-422-4269
[email protected]
Shag Mithun, MD
Principal Investigator
John Theurer Cancer Center at Hackensack UMC
Hackensack New Jersey, 07601, United States More Info
Andrew McConnel
Contact
551-996-5949
[email protected]
Michele Donato, MD
Principal Investigator
Montefiore Medical Center
Bronx New York, 10467, United States More Info
Markenya Mirander
Contact
[email protected]
Joel Victor
Contact
[email protected]
Alejandro Sica, MD
Principal Investigator
Weill Cornell Medicine | NewYork-Presbyterian
New York New York, 10027, United States More Info
Danielle Guarneri
Contact
212-746-0974
[email protected]
Sebastian Mayer, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Daniella Burnetta
Contact
[email protected]
Theresa Elko, MPAS, PA-C
Contact
646.608.3851
Boglarka Gyurkocza, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States More Info
Nicolette Steigerwald
Contact
440-773-4810
[email protected]
Ronald Sobecks, MD
Principal Investigator
Baylor College of Medicine
Houston Texas, 77030, United States More Info
Catherine Robertson
Contact
832-824-5494
[email protected]
Premal Lulla, MD
Principal Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jessica M McCarty
Contact
713-745-5228
[email protected]
Betul Oran, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT04511130

Recruitment Status:

Recruiting

Sponsor:


Marker Therapeutics, Inc.

How clear is this clinincal trial information?

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