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
This study is designed to evaluate the safety and tolerability of using HSC835 in patients with hematological malignancies.

Condition Intervention Phase
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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: January 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSC835
HSC835 infusion
Biological: HSC835


Ages Eligible for Study:   10 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01474681

Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

United States, Minnesota
Novartis Investigative Site Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01474681     History of Changes
Other Study ID Numbers: CHSC835X2201 
Study First Received: November 15, 2011
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
hematologic malignancies

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, B-Cell
Burkitt Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Myelodysplastic Syndromes
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
DNA Virus Infections
Epstein-Barr Virus Infections
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin processed this record on May 26, 2016