Phase 2 N=9 Basic Science

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant

Single Umbilical Cord Blood Transplantation · Non-myeloablative Conditioning · Acute Lymphocytic Leukemia · Myelodysplastic Syndrome · Non-Hodgkin's Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01930162 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Aug 2017

Primary outcome: Primary: Absence of Graft Failure at Day 42 — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: HSC835 (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2016

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	—

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.

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

View full record on ClinicalTrials.gov →

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.