Overview

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

Status:
Active, not recruiting
Trial end date:
2021-11-02
Target enrollment:
0
Participant gender:
All
Summary
The study compares two acute graft-versus-host disease (aGVHD) prophylaxis regimens: CD24Fc vs placebo with the standard GVHD prophylaxis of tacrolimus / methotrexate.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
OncoImmune, Inc.
Treatments:
Methotrexate
Tacrolimus
Criteria
Inclusion Criteria:

1. A prospective participant for allogeneic HCT for a malignant hematologic disorder.

2. The donor and recipient must have a human leukocyte antigen (HLA)-8/8 allelic match at
the HLA-A, -B, -C, and - DRB1 loci. High-resolution typing is required for all alleles
for unmatched donors. Only matched unrelated donors are acceptable for this trial.

3. The following diagnoses are to be included:

1. Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) in first or
second remission. Remission is defined as the absence of blasts in the peripheral
circulation at the time of enrollment, < 5% blasts in the bone marrow and absence
of extramedullary disease including CNS involvement.

2. Myelodysplastic syndrome (MDS) with intermediate or high-risk International
Prognostic Scoring System (IPSS) or equivalent Revised International Prognostic
Scoring System (IPSS-R) score with < 10% blasts in the bone marrow.

4. Males or non-pregnant, non-lactating females, ≥ 18 years of age. Note there is no
defined upper age limited, so long as deemed appropriate candidate for myeloablative
conditioning.

5. Karnofsky Performance Status >70%.

6. Participants must have normal or near normal organ function as defined by their
treating institutions bone marrow transplant (BMT) program clinical practice
guidelines. In addition, for purposes of this protocol minimum organ function criteria
within 30 days of beginning conditioning include: Eligibility According to Pre HCT
Organ Function:

1. Total bilirubin ≤2.5 mg% (unless from Gilbert's disease or disease-related);

2. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
(SGOT))/ alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase
(SGPT)) <5.0 X institutional upper limit of normal;

3. Estimated or actual glomerular filtration rate (GFR)>50 mL/min/1.73 m2 for
participants with creatinine levels above institutional normal (GFR should be
corrected for BSA);

4. Pulmonary Function Tests include diffusing capacity of the lungs for carbon
monoxide (DLCO), forced expiratory volume in one second (FEV1), forced vital
capacity (FVC)> 50% DLCO should be corrected for hemoglobin;

5. Ejection Fraction >50%;

6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≤ 5.

Item d and e may be assessed up to 10 weeks prior to the start of conditioning
therapy.

7. Ability to understand and the willingness to sign a written informed consent document.

8. Women of child bearing potential and men must agree to use contraception prior to
study entry and through day 100 post HCT (hormonal or barrier method of birth control;
abstinence). Should a woman become pregnant or suspect she is pregnant while she or
her partner is on treatment in this study, she should inform her study physician
immediately. Men treated or enrolled on this protocol must also agree to use adequate
contraception prior to the study until day 100 post HCT.

Exclusion Criteria:

1. Subjects may not have presence of active central nervous system (CNS) disease or
extramedullary disease.

2. Prior cytotoxic chemotherapy within 21 days from the initiation of HCT conditioning
(i.e. intensive induction / consolidation for AML). Note, certain low intensity
treatments not intended to induce remission but rather stabilize disease are
acceptable up to 24 hrs prior to initiation of HCT conditioning (i.e. Tyrosine Kinase
Inhibitor, sorafenib).

3. Cord blood and haploidentical donors are not eligible.

4. HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are
permissible.

5. Pregnant and nursing mothers are excluded from this study. This is because the risk to
the fetus is unknown.

6. Any physical or psychological condition that, in the opinion of the investigator,
would pose unacceptable risk to the participant or raise concern that the participant
would not comply with protocol procedures.

7. Uncontrolled infections. Participants still under therapy for presumed or proven
infection are eligible provided there is clear evidence (radiologic, clinical and/or
culture) that the infection is well controlled.

8. Participants seropositive or polymerase chain reaction (PCR) positive for the human
immunodeficiency virus (HIV). Participants with evidence of Hepatitis B or Hepatitis C
PCR positivity.

9. Prior HCT (allograft or prior autograft).

10. Use of T cell depletion either ex vivo or in vivo (i.e. anti-thymocyte globulin (ATG),
alemtuzumab) is prohibited.

11. Current or prior diagnosis of antecedent Myelofibrosis is excluded.