Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Stand… (NCT04539470) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
United States18 participantsStarted 2020-11-19
Plain-language summary
This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Eligible for hematopoietic stem cell transplantation (HSCT)
* 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:
* Prior receipt of autologous or allogeneic HSCT
* 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…
What they're measuring
1
Number of Participants with Adverse Events by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)
Timeframe: From Baseline up to 365 days
2
Change from Baseline in Respiratory Rate Over Time
Timeframe: From Baseline up to 139 days
3
Change from Baseline in Oxygen Saturation Over Time
Timeframe: From Baseline up to 139 days
4
Change from Baseline in Pulse Rate Over Time
Timeframe: From Baseline up to 139 days
5
Change from Baseline in Systolic Blood Pressure Over Time
Timeframe: From Baseline up to 139 days
6
Change from Baseline in Diastolic Blood Pressure Over Time
Timeframe: From Baseline up to 139 days
7
Change from Baseline in Body Temperature Over Time
Timeframe: From Baseline up to 139 days
8
Number of Participants with Laboratory Abnormalities in Hematology Tests