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

Novartis

Status and phase: Completed; Phase 2

Conditions: Acute Lymphocytic Leukemia; Multiple Myeloma; Non-Hodgkin's Lymphoma; Single Umbilical Cord Blood Transplantation; Non-myeloablative Conditioning; Chronic Lymphocytic Leukemia; Myelodysplastic Syndrome

Treatments: Drug: HSC835

Study type: Interventional

Funder types: Industry

Identifiers

NCT01930162

CHSC835X2202

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis that qualifies them for UCBT
• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

HSC835

Experimental group

Description:

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

Treatment:

Drug: HSC835