Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: November 15, 2011
Last updated: February 2, 2016
Last verified: February 2016

November 15, 2011
February 2, 2016
January 2012
August 2017   (final data collection date for primary outcome measure)
Safety and Tolerability: Safety and tolerability will be measured by occurrence of infusional toxicity or occurrence of graft failure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01474681 on Archive Site
  • Incidence of neutrophil recovery [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Incidence of platelet recovery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of mortality, acute graft versus host disease, chronic graft versus host disease, relapse, overall survival, disease-free survival [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies
This study is designed to evaluate the safety and tolerability of using HSC835 in patients with hematological malignancies.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myelocytic Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Chronic Lymphocytic Leukemia
  • Marginal Zone Lymphoma
  • Follicular Lymphomas
  • Large-cell Lymphoma
  • Lymphoblastic Lymphoma
  • Burkitt's Lymphoma
  • High Grade Lymphomas
  • Mantle-cell Lymphoma
  • Lymphoplasmacytic Lymphoma
Biological: HSC835
Experimental: HSC835
HSC835 infusion
Intervention: Biological: HSC835
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2017
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a diagnosis that qualifies them for a DUCBT
  • Absence of recent active mold infection
  • 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
  • Extensive prior chemotherapy
  • Prior myeloablative allotransplantation or autologous transplant.
10 Years to 55 Years
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP