Brief Title
Safety and Tolerability of HSC835 in Patients With Hematological Malignancies
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
Brief Summary
This study evaluated the safety and tolerability of using HSC835 in patients with
hematological malignancies.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.
Secondary Outcome
Incidence of Neutrophil Recovery Within 42 Days
Condition
Acute Myelocytic Leukemia
Intervention
HSC835
Study Arms / Comparison Groups
HSC835
Description: HSC835 infusion
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
27
Start Date
January 9, 2012
Completion Date
October 3, 2016
Primary Completion Date
October 3, 2016
Eligibility 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.
Gender
All
Ages
10 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01474681
Organization ID
CHSC835X2201
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
March 2019