Trials / Terminated

TerminatedNCT03615105

Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

Allogeneic Hematopoietic Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

Summary

This study is being done to learn whether a new method to prevent rejection between the donor immune system and the patient's body is effective.

Type	Name	Description
RADIATION	Hyperfractionated total body irradiation	Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
DRUG	Thiotepa	Thiotepa 5 mg/kg IV
DRUG	Cyclophosphamide	Cyclophosphamide 60 mg/kg IV
DRUG	Busulfan	Busulfan (adult/ped dose)
DRUG	Fludarabine	Fludarabine 25 mg/m2 IV
DRUG	Melphalan	Melphalan 70 mg/m2 IV
DRUG	Clofarabine	Clofarabine 20-30 mg/m2 IV
PROCEDURE	HPC(A) stem cell allograft	All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
DRUG	Rituximab	Rituximab 200 mg IV flat dose
DEVICE	Rabbit antithymocyte globulin	Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03615105. Inclusion in this directory is not an endorsement.