Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies

Recruiting Early Phase 1 Interventional Study
Hematologic Malignancy Bone Marrow Transplant Rejection Acute Myeloid Leukemia (AML) Myelodysplastic Syndromes (MDS) Acute Lymphoblastic Leukemia (ALL), Adult Multiple Myeloma Aplastic Anemia Lymphoma Non Hodgkin Lymphoma Hodgkin Lymphoma Chronic Myeloid Leukemia Myelofibrosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
8 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
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About This Trial
This research is being done to investigate the safety and effectiveness of Darzalex Faspro (daratumumab and hyaluronidase-fihj) (a monoclonal antibody that targets plasma cells that make antibodies) and whether it can lower donor specific antibodies (DSA) levels to low enough levels to permit patients to proceed with allogeneic peripheral blood transplant (alloBMT). Those being asked to participat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transplant (RIC alloHSCT) as defined in Johns Hopkins BMT Policy; all potential non-cord blood donor sources are included: matched rela…
Contacts

Christian B Gocke, MD PhD

4109558839

cgocke2@jhmi.edu

CONTACT

Amanda Stevens, MD

7869994146

msteve35@jhmi.edu

CONTACT