drugset / Trial / NCT02629120

High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous Disease

NCT02629120 ↗

Phase 1/2 Active not recruiting 45 enrolled National Institute of Allergy and Infectious Diseases (NIAID)
NaSingle-groupOpen-labelTreatment

Summary

Chronic granulomatous disease (CGD) affects white blood cell function. Currently, the only curative treatment is bone marrow transplant to replace the abnormal stem cells with new ones (donor cells) capable of making a normal immune system. Transplant problems include graft versus host disease (GvHD) and graft rejection. With GvHD, donor cells attack the recipient s normal tissue. Researchers want to use preparation drugs and a high cell dose to increase graft success. They want to use 2 immunosuppressive drugs (cyclophosphamide and sirolimus) to lessen the risk of GvHD.

Timeline

Start
2015-12-17
Primary completion
2027-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alemtuzumab Monoclonal antibody — —
Comparator Busulfan Small molecule — —
Comparator Cyclophosphamide Other / unclassified — —
Comparator Peripheral blood stem cells Cell therapy — —
Comparator Sirolimus Small molecule — —