NCT01930162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 7, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed
Last Updated

January 5, 2021

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

August 23, 2013

Results QC Date

July 12, 2017

Last Update Submit

December 9, 2020

Conditions

Single Umbilical Cord Blood TransplantationNon-myeloablative ConditioningAcute Lymphocytic LeukemiaMyelodysplastic SyndromeNon-Hodgkin's LymphomaMultiple MyelomaChronic Lymphocytic Leukemia

Keywords

HSC835single umbilical cord blood transplantationnon-myeloablative conditioning regimenUmbilical cord bloodUCB transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of Neutrophil Recovery Within 42 Days

    42 days

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

    1 year

  • Incidence of Overall Survival Within One Year

    1 year

  • Incidence of Relapse-free Survival Within One Year

    1 year

Study Arms (1)

HSC835

EXPERIMENTAL

Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.

Drug: HSC835

Interventions

HSC835DRUG

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

HSC835

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis that qualifies them for UCBT
  • Adequate organ function
  • Availability of eligible donor material

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLymphoma, Non-HodgkinMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

October 7, 2014

Primary Completion

August 29, 2016

Study Completion

August 29, 2016

Last Updated

January 5, 2021

Results First Posted

August 10, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)