Hematopoietic Stem Cell TransplantationPhase 3CATHYNCT04095858
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)
A Phase 3 study testing Efprezimod alfa, Methotrexate and Tacrolimus in people with Hematopoietic Stem Cell Transplantation and Acute Graft Versus Host Disease, run by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease, Acute Myeloid Leukemia
- What is being tested?
- Efprezimod alfa, Methotrexate and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Jan 2021to 5 Nov 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A prospective participant for allogeneic HCT for a malignant hematologic disorder.
- 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.
- The following diagnoses are to be included:
- 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.
- 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.
- 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.
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- Karnofsky Performance Status >70%.
- 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:
- Total bilirubin ≤2.5 mg% (unless from Gilbert's disease or disease-related);
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT))/ alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) <5.0 X institutional upper limit of normal;
- 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);
- 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;
- Ejection Fraction >50%;
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
- 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.
Who cannot join
- Subjects may not have presence of active central nervous system (CNS) disease or extramedullary disease.
- 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).
- Cord blood and haploidentical donors are not eligible.
- HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are permissible.
- Pregnant and nursing mothers are excluded from this study. This is because the risk to the fetus is unknown.
- 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.
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- 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.
- 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.
- Prior HCT (allograft or prior autograft).
- Use of T cell depletion either ex vivo or in vivo (i.e. anti-thymocyte globulin (ATG), alemtuzumab) is prohibited.
- Current or prior diagnosis of antecedent Myelofibrosis is excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Chicago Medical Center ( Site 0306)
Chicago, Illinois, 60637
City of Hope ( Site 0302)
Duarte, California, 91010
Penn State University Milton S. Hershey Medical Center ( Site 0304)
Hershey, Pennsylvania, 17033
Abramson Cancer Center of the University of Pennsylvania ( Site 0309)
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-Versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
The Sponsor decided to discontinue screening and enrollment in this study on 18 May 2021 for business reasons. This decision was not related to any new or unexpected safety or efficacy findings.
- Conditions
- Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Being tested
- Efprezimod alfa, Placebo, Methotrexate, Tacrolimus
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efprezimod alfaDrug
Also called Human CD24 and human IgG Fc Fusion Protein, MK-7110
IV infusion: 480 mg at Day -1, 240 mg at Day 14, 240 mg at Day 28.
PlaceboDrug
Also called Saline
IV infusion, 100 ml at Day -1, Day 14, and Day 28.
MethotrexateDrug
Also called Trexall
IV, 15 mg/m^2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11.
TacrolimusDrug
Also called FK506, Prograf
Begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted
| Study group | Role | What they receive |
|---|---|---|
| Efprezimod alfa Treatment | Experimental | Efprezimod alfa: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV [0.03 mg/kg/day] or by mouth (PO) [0.045 mg/kg/dose] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m^2/dose on days 3, 6, and 11 after HCT. Receives: Drug: Efprezimod alfa; Drug: Methotrexate; Drug: Tacrolimus |
| Placebo | Placebo comparator | Placebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV [0.03mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m^2/dose on days 3, 6, and 11 after HCT. Receives: Drug: Placebo; Drug: Methotrexate; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
180 Day Grade III-IV Acute Graft-Versus-Host Disease (GVHD)-Free Survival (aGFS)
Grade III-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade III-IV GVHD or death by any cause in 180 days after hematopoietic stem cell transplantation (HCT). Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
Measured: Up to 180 days after HCT
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time from HCT to death due to any cause. Participants who were alive at the end of the 180 days post HCT were censored at the last date they were known to be alive.
Measured: Up to 180 days after HCT
Disease Free Survival (DFS)
DFS is defined as the earlier of time to leukemia relapse, or death, whichever occurred first. Subjects that were alive and did not experience disease relapse at the end of the follow-up period (180 days after HCT) were censored at the last date of evaluation.
Measured: Up to 180 days after HCT
180 Day Grade II-IV aGFS
Grade II-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade II-IV GVHD or death by any cause in 180 days after HCT. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
Measured: Up to 180 days after HCT
180 Day Grade III-IV aGVHD-free and Relapse-free Survival (aGVHD RFS)
Grade III-IV aGVHD RFS was defined as the time in days to the earlier of the first documented acute Grade III-IV aGVHD, relapse, or death by any cause in 180 days after HCT. Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out, experience Grade III-IV aGVHD, relapse, or death were censored at Day 180.
Measured: Up to 180 days after HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start5 Jan 2021
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Why it stopped: Business Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095858
- Sponsor's protocol ID
- 7110-005
- Other IDs
- 15-4789, FD-OOPD-006089, CD24Fc-005, MK-7110-005
- Acronym
- CATHY
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2019
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-Versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04095858
- Acronym / sponsor ID
- CATHY / 7110-005
- Conditions
- Hematopoietic Stem Cell Transplantation, Acute Graft Versus Host Disease, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reasons
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 14 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Sponsor decided to discontinue screening and enrollment in this study on 18 May 2021 for business reasons. This decision was not related to any new or unexpected safety or efficacy findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efprezimod alfa Treatment | Experimental | Drug: Efprezimod alfa, Drug: Methotrexate, Drug: TacrolimusEfprezimod alfa: IV infusion, 480 mg (day -1), 240 mg (day +14) and 240 mg (day +28); Tacrolimus: begin on day -3. IV [0.03 mg/kg/day] or by mouth (PO) [0.045 mg/kg/dose] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m^2/dose once daily on Day 1 after hematopoietic cell transplantation (HCT), and at a dose of 10 mg/m^2/dose on days 3, 6, and 11 after HCT. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Methotrexate, Drug: TacrolimusPlacebo (Saline solution): 100 ml IV infusion, Day -1, Day 14, Day 28. Tacrolimus: begin on day -3. IV [0.03mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted; Methotrexate: given IV at a dose of 15 mg/m^2/dose once daily on Day 1 after HCT, and at a dose of 10 mg/m^2/dose on days 3, 6, and 11 after HCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A prospective participant for allogeneic HCT for a malignant hematologic disorder.
- 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.
- The following diagnoses are to be included:
- 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.
- Karnofsky Performance Status >70%.
Key exclusion criteria (11 listed)
- Subjects may not have presence of active central nervous system (CNS) disease or extramedullary disease.
- 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).
- Cord blood and haploidentical donors are not eligible.
- HLA-mismatch at the HLA-A, -B, -C, and - DRB1 loci. Note, HLA-DQ mismatches are permissible.
- Pregnant and nursing mothers are excluded from this study. This is because the risk to the fetus is unknown.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efprezimod alfaAlso: Human CD24 and human IgG Fc Fusion Protein, MK-7110IV infusion: 480 mg at Day -1, 240 mg at Day 14, 240 mg at Day 28. | Drug | Efprezimod alfa Treatment |
| PlaceboAlso: SalineIV infusion, 100 ml at Day -1, Day 14, and Day 28. | Drug | Placebo |
| MethotrexateAlso: TrexallIV, 15 mg/m^2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11. | Drug | Efprezimod alfa Treatment, Placebo |
| TacrolimusAlso: FK506, PrografBegin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted | Drug | Efprezimod alfa Treatment, Placebo |
Primary outcome
180 Day Grade III-IV Acute Graft-Versus-Host Disease (GVHD)-Free Survival (aGFS)
Time frame: Up to 180 days after HCT
Grade III-IV aGFS was defined as the time in days to the earlier of the first documented acute Grade III-IV GVHD or death by any cause in 180 days after hematopoietic stem cell transplantation (HCT). Event grading was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 criteria. Participants who did not drop out or experience aGVHD or death were censored at the time of leukemia relapse or Day 180, whichever came first.
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 180 days after HCT
Disease Free Survival (DFS)
Time frame: Up to 180 days after HCT
180 Day Grade II-IV aGFS
Time frame: Up to 180 days after HCT
180 Day Grade III-IV aGVHD-free and Relapse-free Survival (aGVHD RFS)
Time frame: Up to 180 days after HCT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Oncology Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efprezimod alfa, Methotrexate and Tacrolimus in people with Hematopoietic Stem Cell Transplantation and Acute Graft Versus Host Disease, run by Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
180 Day Grade III-IV Acute Graft-Versus-Host Disease (GVHD)-Free Survival (aGFS) (time frame: Up to 180 days after HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.