Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide

PHASE1CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Hodgkin's LymphomaLeukemiaMyelodysplastic Syndrome(MDS)Multiple MyelomaNon Hodgkin's Lymphoma
Interventions
DRUG

Cyclophosphamide

Days -6 and -5: 14.5 mg/kg/day IV. Days 3 and 4: 50 mg/kg/day IV.

DRUG

Fludarabine

Days -6, -5, -4, -3, and -2: 30 mg/m\^2/day IV.

RADIATION

Total body irradiation

Day -1: 200 centigray in one fraction.

DRUG

Mycophenolate Mofetil

Days 5 to 35: 15 mg/kg PO three times per day; max daily dose 1 g.

DRUG

Tacrolimus 60

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 60.

DRUG

Tacrolimus 90

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 90.

DRUG

Tacrolimus 120

Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 120.

BIOLOGICAL

Bone marrow transplant

Donor stem cells infused IV on Day 0.

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

All Listed Sponsors
lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT01342289 - Shorter Course Tacrolimus After Nonmyeloablative, Related Donor BMT With High-dose Posttransplantation Cyclophosphamide | Biotech Hunter | Biotech Hunter