||MT2013-10: A single-arm, open-label, proof-of-concept study to evaluate the safety and tolerability of infusing HSC835
in patients with hematological malignancies using a non-myeloablative conditioning regimen
||Study 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 DUCBT with NMA conditioning.
||Patients will undergo an UCBT consisting of the investigational therapy of
HSC835 (expanded CD34+ fraction of the UCB unit) followed by the infusion
of the CD34-negative fraction removed from the unit prior to the expansion
||This is a non-confirmatory, single arm, open-label, study to investigate the
safety and tolerability of HSC835 in patients with hematologic malignancies
requiring umbilical cord blood transplant (UCBT) with a non-myeloablative
(NMA) conditioning regimen.
||Patients between the ages of 18 and 70 with hematologic malignancies requiring UCBT using an NMA conditioning regimen.
|Applicable Disease Sites
Myeloid and Monocytic Leukemia
||CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
Total Body irradiation (TBI)
||Masonic Cancer Center
||Patients between the ages of 18 and 70 with hematologic malignancies requiring UCBT using an NMA conditioning. A total of three suitable Umbilical Cord Blood Units must be available. Patients must have adequate organ function and have no evidence of
progressive disease by imaging modalities or biopsy. Patients can not have an active infection within 7 days of transplantation (including active infection with Aspergillus or other mold within 30 days) Patients who have CML in refractory blast crisis or large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy are not eligible. A signed informed consent and HIPPA authorization is required.