Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
NCT ID: NCT04539470
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2020-11-19
2023-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Cohort A: Efmarodocokin Alfa Dosage Level 1
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 1 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
Efmarodocokin Alfa
Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
Cohort B: Efmarodocokin Alfa Dosage Level 2
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 2 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
Efmarodocokin Alfa
Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
Cohort C: Efmarodocokin Alfa Dosage Level 3
Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 3 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices.
Efmarodocokin Alfa
Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
Interventions
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Efmarodocokin Alfa
Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Donor meeting human leukocyte antigen (HLA) matching criteria of HLA-matched related or HLA-matched unrelated (HLA-A, HLA-B, HLA-C, and HLA-DRB1, eight out of eight) from either peripheral blood or bone marrow stem cells and meeting donor-eligibility criteria as outlined by the U.S. Food and Drug Administration (FDA) in 21 CFR 1271 (including screening for Zika and SARS-CoV-2 exposure or infection)
* Planned HLA (HLA-A, HLA-B, HLA-C, and HLA-DRB1)-matched (eight out of eight) related or planned HLA-matched (eight out of eight) unrelated HSCT, from either peripheral blood or bone marrow stem cells, for patients with acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) in first complete remission (per institutional criteria) or patients with intermediate or high-risk myelodysplastic syndrome (MDS)
* Planned myeloablative conditioning regimen per institutional guidelines
* Planned aGvHD prophylaxis consisting of tacrolimus and methotrexate; in cases of tacrolimus intolerance, cyclosporine or sirolimus may be used as a substitute
Exclusion Criteria
* Diagnosis of myelofibrosis or myelodysplastic/myeloproliferative overlap syndrome
* Treatment with investigational biologic or non-biologic therapy within 5 drug elimination half-lives (or within 90 days or 30 days, respectively, if half-life is unknown) prior to initiation of study drug
* Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serologies
* History of Grade \>1 cervical intraepithelial neoplasia
* A marked baseline prolongation of QT/QTc interval
* Risk factors for torsades de pointes
* Pregnant or breastfeeding
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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City of Hope
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of Miami Miller School of Medicine; Clinical Reseach Building
Miami, Florida, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum
Kansas City, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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GA41825
Identifier Type: -
Identifier Source: org_study_id
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