Trial intelligence / Profile preview

HSC835 in hematological malignancies

NCT01474681Phase 2

Key facts

Status: Completed
Start: Jan 2012
Primary completion: Oct 2016
Countries: 1
Sponsor: Novartis

Drugs: spanlecortemlocel
Conditions: hematologic malignancy

Overview

Phase 2, open-label, single-arm trial of spanlecortemlocel in hematologic malignancy, sponsored by Novartis. Primary endpoints: Infusional Toxicity at 48 hours and Absence of Graft Failure at 32 days. Started Jan 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

HSC835
Infusion of HSC835 (spanlecortemlocel)

Who it enrols

Patients with high-risk hematological malignancies eligible for double umbilical cord blood transplant, aged 10-55 years, with adequate organ function and no active infection or HIV.

Endpoints

Primary

Infusional Toxicity48 hours
Absence of Graft Failure32 days

Secondary

Incidence of Neutrophil Recovery42 days
Incidence of Platelet Recovery6 months
Frequency of Expanded Unit PredominanceDay 100
Transplant Related Mortality1 year
Acute Graft Versus Host Disease100 days
Chronic Graft Versus Host Disease1 year
Incidence of Relapse1 year
Overall Survival1 year

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