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 evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.
Phase 1/Phase 2
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.
Incidence of Neutrophil Recovery Within 42 Days
Acute Myelocytic Leukemia
Study Arms / Comparison Groups
Description: HSC835 infusion
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 9, 2012
October 3, 2016
Primary Completion Date
October 3, 2016
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.
10 Years - 55 Years
Accepts Healthy Volunteers
Novartis Pharmaceuticals, ,
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals