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NCT01930162 Clinical Trial

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

Multiple Myeloma Clinical Trial

— UCBT  

Official title:
A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01930162
Other study ID # CHSC835X2202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 7, 2014
Est. completion date August 29, 2016

Study information
Verified date August 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date August 29, 2016
Est. primary completion date August 29, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• HSC835
HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).

Locations
Country Name City State
United States Novartis Investigative Site Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of Graft Failure at Day 42 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. 42 days
Secondary Incidence of Neutrophil Recovery Within 42 Days Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L. 42 days
Secondary Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration. 1 year
Secondary Incidence of Overall Survival Within One Year Overall survival is the proportion of patients who were alive at the end of the one year study period. 1 year
Secondary Incidence of Relapse-free Survival Within One 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. 1 year
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