PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 6, 2018

Primary Completion Date

March 2, 2022

Study Completion Date

April 1, 2023

Conditions
Hematologic Malignancy
Interventions
DRUG

Tacrolimus

Tacrolimus will be given intravenously at a dose of 0.03 mg/kg/day starting Day -3. Subsequent dosing will be based on blood levels.

DRUG

Methotrexate

Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic cell infusion.

DRUG

Tocilizumab

Tocilizumab will be administered intravenously (IV) at a dose of 8 mg/kg (maximum dose of 800 mg) once on the Day -1 approximately 24 hours prior to the estimated time of the hematopoietic cell infusion, and subsequently, on Day +100 (+/- 14 days, i.e., Days +86 to +114) post-alloHCT. The infusion will be administered over 60 minutes through a dedicated IV line and must not be administered by IV bolus.

Trial Locations (1)

53226

Froedtert Hospital, Milwaukee

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

Medical College of Wisconsin

OTHER

NCT03699631 - PROACTIVE: Preventing Acute/Chronic GVHD With TocIlizumab Combined With GVHD Prophylaxis Post allogEneic Transplant | Biotech Hunter | Biotech Hunter