Optimizing PTCy Dose and Timing

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 9, 2019

Primary Completion Date

November 25, 2025

Study Completion Date

October 26, 2026

Conditions
Graft Versus Host DiseaseHematologic Neoplasms
Interventions
DRUG

Busulfan

Busulfan should be administered intravenously via a central venous catheter as a three-hour infusion every 24 hours.

DRUG

Fludarabine

Fludarabine will be infused by IV over 60 minutes.

DRUG

Cyclophosphamide

IV cyclophosphamide will be administered over 2 hours. Slower rates of infusion may be used to decrease side effects. A fluid intake of greater than 2 L/day is recommended during and for 1 to 2 days after cyclophosphamide administration.

DRUG

Mycophenolate Mofetil

Any oral formulation should be taken on an empty stomach, 1 hour before or at least 2 hours after meals. Oral formulations should not be administered simultaneously with antacids. Avoid inhalation or direct contact with skin or mucous membranes of dry powder contained in capsules or suspension. IV solutions should be administered over at least two hours through either a peripheral or central vein and should not be administered by rapid or bolus injection.

DRUG

Sirolimus

Oral tablets should be administered approximately 4 hours after cyclosporine administration. Sirolimus is administered orally, once daily, without food. Patients unable to tolerate tablets may take the oral solution formulation.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

National Cancer Institute (NCI)

NIH