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Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474681
First received: November 15, 2011
Last updated: February 14, 2017
Last verified: February 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Incidence of neutrophil recovery [ Time Frame: 42 days ]
  • Incidence of platelet recovery [ Time Frame: 6 months ]
  • Incidence of mortality, acute graft versus host disease, chronic graft versus host disease, relapse, overall survival, disease-free survival [ Time Frame: 100 days ]

Enrollment: 27
Study Start Date: January 2012
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSC835
HSC835 infusion
Biological: HSC835

  Eligibility

Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT01474681

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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01474681     History of Changes
Other Study ID Numbers: CHSC835X2201
Study First Received: November 15, 2011
Last Updated: February 14, 2017

Keywords provided by Novartis:
hematologic malignancies
leukemia
lymphoma

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

ClinicalTrials.gov processed this record on April 25, 2017