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Patients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.

HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).

HSC835

Novartis Pharmaceuticals

This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant

A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.

Engraftment is defined as the first of three consecutive days with ANC \> 0.5 x 109/L.

NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.

Overall survival is the proportion of patients who were alive at the end of the one year study period.

Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.

Adverse events that occurred within the first 48 hours of transplant.

Time Period From Transplant Until 48hrs After Transplant

Adverse Events that occurred 48 hours post-transplant.

Time Period From Day 3 up to End of Study

Age, Continuous

Sex: Female, Male

Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).

Spots Global Cancer Trial Database for single umbilical cord blood transplantation