Text Size

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474681
First received: November 15, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes

November 15, 2011
March 21, 2013
January 2012
December 2014   (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 ClinicalTrials.gov 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
Not Provided
 
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
Interventional
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
Intervention: Biological: HSC835
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
December 2014
December 2014   (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.
Both
10 Years to 55 Years
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States
 
NCT01474681
CHSC835X2201
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

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