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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
  Purpose

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:

U.S. FDA Resources

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: 18
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSC835 Biological: HSC835

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474681

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

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01474681     History of Changes
Other Study ID Numbers: CHSC835X2201
Study First Received: November 15, 2011
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
hematologic malignancies
leukemia
lymphoma

Additional relevant MeSH terms:
Burkitt Lymphoma
Neoplasms
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Myelodysplastic Syndromes
 Preleukemia
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell
Hematologic Neoplasms
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on June 18, 2013