Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 4, 2018

Primary Completion Date

April 3, 2025

Study Completion Date

April 3, 2030

Conditions
Lymphoproliferative DisordersAutoimmune LymphoproliferativePrimary T-cell Immunodeficiency DisordersImmune System DiseasesCommon Variable Immunodeficiency
Interventions
DRUG

Immunosuppression Only Conditioning

E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -9 and -5, cyclophosphamide:5 mg/kg orally daily on days -9 through -2

DRUG

Reduced Intensity Conditioning

E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -11 and -7, cyclophosphamide:3 mg/kg orally daily on days -11 through -4 Busulfan IV, pharmokinetically dosed, on days -3 and -2.

DRUG

GVHD Prophylaxis

High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, Mesna: 25-50 mg/kg weight based dosing, Tacrolimus 0.02 mg/kg on days +5 through +90, and mycophenolate mofetil (MMF) 15 mg/kg on days +5 through +25

PROCEDURE

Allogeneic HSC

Stem cell transplant

Trial Locations (2)

20892

National Institutes of Health Clinical Center, Bethesda

55401

National Marrow Donor Program, Minneapolis

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT03663933 - Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation | Biotech Hunter | Biotech Hunter