Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2021

Conditions
Severe Aplastic AnemiaBone Marrow Failure Syndromes
Interventions
PROCEDURE

Bone marrow transplant

Day 0

DRUG

Thymoglobulin

0.5 mg/kg IV on Day -9 2 mg/kg IV on Days -8, -7

DRUG

Fludarabine

30 mg/M2 IV on days -6 to -2

DRUG

Cyclophosphamide

14.5 mg/kg IV on days -6, -5, 3, 4

RADIATION

TBI

200 cGy on day -1

DRUG

Mesna

40 mg/kg IV on days 3, 4

DRUG

Tacrolimus

For patients 18 years or older, tacrolimus will be given per institutional standards; may be increased or later changed to a PO BID schedule. Treatment to continue until Day 365 or longer if GVHD present

DRUG

Mycophenolic acid mofetil

15 mg/kg PO/IV TID beginning on day 5 through day 35

Trial Locations (2)

21287

The Sidney Kimmel Comprehensive Cancer Center, Baltimore

53226

Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee

All Listed Sponsors
lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02224872 - Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia | Biotech Hunter | Biotech Hunter