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

December 9, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HSC835
Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Graft Failure at Day 42
Time Frame: 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.
42 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2014

Primary Completion (ACTUAL)

August 29, 2016

Study Completion (ACTUAL)

August 29, 2016

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (ESTIMATE)

August 28, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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