Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06398457 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseEarly Phase 1
Started2024-09-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Amendment history

2026-09-25
critical
Primary completion pushed: 2026-09 → 2027-09
Completion pushed: 2027-03 → 2028-03
2025-09-25
minor
Study Status v4
Re-verified, no change to tracked fields
2024-09-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09→confirmed 2024-09-19
Study sites0→1
2024-08-26
minor
Study Status v2
Primary completion date2026-08→2026-09
Completion date2027-02→2027-03
Start date2024-08→2024-09
2024-07-10
minor
Study Status v1
Primary completion date2026-06→2026-08
Completion date2026-12→2027-02
Start date2024-06→2024-08
2024-05-02
minor
Original filing
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 stem cell transplant.
Trial Details
NCT Number NCT06398457
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Janssen Research & Development, LLC
Conditions Hematologic Malignancy, Bone Marrow Transplant Rejection, Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Acute Lymphoblastic Leukemia (ALL), Adult, Multiple Myeloma, Aplastic Anemia, Lymphoma +4 more
Enrollment 8 participants
Start Date 2024-09-19
Primary Completion 2027-09 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-24