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

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 participate have high DSA levels that puts those being asked to participate at high risk of rejecting the available donor's blood stem cells and making those being asked to participate ineligible to receive a s

Trial Details

NCT ID
NCT06398457
Phase
EARLY_PHASE1
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Darzalex Faspro (Daratumumab and hyaluronidase-fihj)
  • JH-DSA Semi-Quant Screen and Response Score
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Participates must meet all other institutional criteria for the planned reduced intensity conditioning allogeneic peripheral blood stem cell transp…
  • Participants must be ≥18 years of age.
  • Participants must have adequate organ function for undergoing RIC allogeneic peripheral blood stem cell transplant, and for undergoing a clinical t…
  • a. Hematologic. i. White blood cell (WBC). ANC ≥ 500/mm3 (growth factor support allowed). ii. Hemoglobin. No specific cut-off. (PRBC transfusion al…

For full eligibility, visit ClinicalTrials.gov.

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