Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow

PHASE2CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

April 15, 1999

Primary Completion Date

December 14, 2018

Study Completion Date

June 18, 2020

Conditions
Myeloproliferative DisordersAcute Myelogenous LeukemiaChronic Myelogenous LeukemiaMyelodysplastic SyndromeAcute Lymphoblastic Leukemia
Interventions
PROCEDURE

T-cell replete PBPC allograft

Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m2 intravenously (IV) over 30 minutes daily x 5 days with or without ATG followed by a PBPC graft targeted to deliver \>5x10\^6 CD34+ cells/kg.

DRUG

Methotrexate

IV MTX on days +1, +3, and +6 will be given

DRUG

Cyclosporine

CSA will be given beginning on day -4 for graft versus host disease prophylaxis. Participants with mixed T-cell chimerism on day 30 will begin a CSA taper. Participants with 100% donor T-cell chimerism by day 30 will be tapered off CSA from days 60 through 100 (25% reduction in dose every 10 days-off by day 100). CSA will not be tapered in any subjects with grade \> II acute GVHD regardless of chimerism results. In addition, participants with evidence of disease progression without grade \> II GVHD will have CSA discontinued regardless of chimerism results.

DRUG

G-CSF

G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT00003838 - Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow | Biotech Hunter | Biotech Hunter