NCT01930162 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-01-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Absence of Graft Failure at Day 42

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outcome · POSTED

Incidence of Neutrophil Recovery Within 42 Days

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outcome · POSTED

Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year

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outcome · POSTED

Incidence of Overall Survival Within One Year

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outcome · POSTED

Incidence of Relapse-free Survival Within One Year

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
intervention Names
Drug: HSC835
label
HSC835
type
EXPERIMENTAL

interventions

arm Group Labels
HSC835
description
HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
name
HSC835
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

BASIC_SCIENCE

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Absence of Graft Failure at Day 42
time Frame
42 days

secondary Outcomes

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

Full study description

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.

Source references