Phase 2
Completed N=9
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant
Single Umbilical Cord Blood Transplantation · Non-myeloablative Conditioning · leukemia · Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT01930162 ↗
Enrolled (actual)
9
Serious AEs
50.0%
Results posted
Aug 2017
Primary outcomePrimary: Absence of Graft Failure at Day 42 — 0 Participants
Summary
This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Graft Failure at Day 42 |
— | — |
| SECONDARY Incidence of Neutrophil Recovery Within 42 Days |
9 | — |
| SECONDARY Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year |
1 | — |
| SECONDARY Incidence of Overall Survival Within One Year |
5 | — |
| SECONDARY Incidence of Relapse-free Survival Within One Year |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis that qualifies them for UCBT
- Adequate organ function
- Availability of eligible donor material
Exclusion Criteria
- Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
- Human immunodeficiency virus (HIV) infection
- Active infection
Data sourced from ClinicalTrials.gov (NCT01930162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.