Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

April 18, 2019

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2030

Conditions
Peripheral T-cell LymphomasLymphoproliferative DisordersImmune System Diseases
Interventions
DRUG

ATL-RIC

e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, low-dose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5mcg /kg/day subcutaneous on days -12, -8, and -4, ruxolitinib 45 mg/day from day -12 through day -2, and zidovudine 300mg orally three times a day from day -1 through day +50.

DRUG

mRIC

e-ATG 40 mg/kg/day IV on days -14 and -13, pentostatin 4 mg/m2/day IV on days -11 and -7, lowdose cyclophosphamide (5 mg/kg) orally daily on days -11 through -4; busulfan IV, pharmacokinetically dosed, on days -3 and -2, filgrastim or biosimilar drug 5 mcg/kg/day subcutaneous on days -12, -8, and -4.

PROCEDURE

allo HCT

Stem cell transplant

DRUG

RIC

e-ATG 40 mg/kg/day IV on days -14 and -13. Pentostatin 4mg /m2/day IV on days -11 and -7. Cyclophosphamide 5 mg/kg orally daily on days -11 through -4. Busulfan IV, pharmacokinetically dosed, on days -3 and -2.

DRUG

GVHD prophylaxis

"High-dose, post-transplantation cyclophosphamide (PTCy) on days +3~and +4 ( 25 mg/kg/day on both arms), sirolimus on days +5 through +60, and mycophenolate mofetil (MMF) on~days +5 through +25."

DRUG

IOC

e-ATG40 mg/kg/day IV 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

Trial Locations (2)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

55401

ENROLLING_BY_INVITATION

National Marrow Donor Program, Minneapolis

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH