NCT02556931View on ClinicalTrials.gov

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

April 30, 2021

Study Completion Date

April 30, 2021

Conditions
Myelodysplastic SyndromeChronic Myelomonocytic LeukemiaSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaProlymphocytic LeukemiaChronic Myeloid LeukemiaChronic Myeloproliferative DisordersMultiple MyelomaPlasma Cell NeoplasmPlasma Cell DyscrasiaMyelofibrosisPolycythemia VeraEssential ThrombocythemiaPlasma Cell Leukemia
Interventions
DRUG

Fludarabine

Days -6 through -2: 30 mg/m\^2 IV daily

DRUG

Cyclophosphamide

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

RADIATION

Total body irradiation

Day -1: 200 cGy in a single fraction

DRUG

Tacrolimus

Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status.

DRUG

Mycophenolate mofetil

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

Trial Locations (1)

21287

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02556931 - Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies | Biotech Hunter | Biotech Hunter