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Completed

NCT Number: NCT01930162

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

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.

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Key information

Conditions

Single Umbilical Cord Blood Transplantation Acute Lymphocytic Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non-Hodgkin's Lymphoma Non-myeloablative Conditioning Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HSC835

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: UCBT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2013
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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