AML: Treatment of Relapse after Transplant or Extended Maintenance of Remission – Investigational Study (ARTEMIS) Effectiveness of MT-401 in Patients with AML Following Stem Cell Transplant

Overview

About this study

The purpose of this study is to evaluate safety and effectiveness of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

1. 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

2. Are ≥18 years of age

3. Karnofsky/Lansky score of ≥60

4. Life expectancy ≥12 weeks

5. 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

1. Clinically significant or severely symptomatic intercurrent infection

2. Pregnant or lactating

3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of
MT-401

4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401

5. 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mithun Shah, M.D., Ph.D.

Open for enrollment

Contact information:

Anton Mett CCRP

(507) 538-9812

Mett.Anton@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20532366

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