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Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)

NCT04095858 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-02-08

Study results available
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Summary

The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.

The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: efprezimod alfa/tacrolimus / methotrexate (efprezimod alfa/Tac/MTX) versus placebo/tacrolimus / methotrexate (placebo/Tac/MTX) in the setting of myeloablative conditioning (MAC), matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation in participants with acute leukemia (AML/ALL) or myelodysplastic syndrome (MDS). The study agent, efprezimod alfa, will be administered through IV infusion on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively. The placebo will be 100 ml normal saline intravenous (IV) solution.

Conditions

Interventions

DRUG

Efprezimod alfa

IV infusion: 480 mg at Day -1, 240 mg at Day 14, 240 mg at Day 28.

DRUG

Placebo

IV infusion, 100 ml at Day -1, Day 14, and Day 28.

DRUG

Methotrexate

IV, 15 mg/m\^2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11.

DRUG

Tacrolimus

Begin on day -3. IV \[0.03 mg/kg/day\] or PO \[0.045 mg/kg/dose\] dosing is permitted

Sponsors & Collaborators

  • Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-11-05
Completion
2021-11-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04095858 on ClinicalTrials.gov