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

Phase 2

Completed

• Conditions: Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia
• Interventions: Drug: HSC835

• Registration Number: NCT01930162
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-23
• Study First Posted: 2013-08-28
• Study Start: 2014-10-07
• Primary Completion: 2016-08-29
• Study Completion: 2016-08-29
• Results First Submitted: 2017-07-12
• Results First Submitted QC: 2017-07-12
• Status Verified: 2017-08
• Results First Posted: 2017-08-10
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSC835	HSC835	Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.

Primary Outcome Measures

Name	Time	Method
Absence of Graft Failure at Day 42	42 days	This endpoint was to study safety and tolerability of HSC835 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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Overall Survival Within One Year	1 year	Overall survival is the proportion of patients who were alive at the end of the one year study period.
Incidence of Neutrophil Recovery Within 42 Days	42 days	Engraftment is defined as the first of three consecutive days with ANC \> 0.5 x 109/L.
Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year	1 year	NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.
Incidence of Relapse-free Survival Within One Year	1 year	Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Minneapolis, Minnesota, United States