Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Chronic Myeloproliferative DisordersGraft Versus Host DiseaseInfectionLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsPrecancerous ConditionSecondary MyelofibrosisSmall Intestine Cancer
Interventions
BIOLOGICAL

anti-thymocyte globulin

0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.5 mg/kg on day -1 or day 0 from stem cell transplant

DRUG

cyclophosphamide

60mg/kg on days -5 and -4 from stem cell transplant

DRUG

etoposide

60mg/kg on day -4 from stem cell transplant

DRUG

fludarabine phosphate

Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant

DRUG

melphalan

Melphalan 140 mg/m2 on day -4 from stem cell transplant

DRUG

methotrexate

For high risk HLA-mismatch transplant only: 5 mg/m2 on days +1, +3 and +6 from stem cell transplant

DRUG

sirolimus

"Adults: 12 mg loading dose on day -3 from stem cell transplant followed by 4 mg orally single morning daily dose.~Pediatric Patients \<40kg: 3 mg/m2 orally on day -3 from stem cell transplant followed by 1 mg/m2 orally single morning daily dose"

DRUG

tacrolimus

0.02 mg/kd/d CIV beginning on day -3 from stem cell transplant

PROCEDURE

allogeneic hematopoietic stem cell transplantation

The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight

PROCEDURE

hematopoietic stem cell transplantation

The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Fludarabine 25 mg/m2/d from days -9 to -5 from stem cell transplant, Melphalan 140 mg/m2 on day -4 from stem cell transplant

PROCEDURE

peripheral blood stem cell transplantation

The target peripheral blood stem cell dose will be 5-10 x 106/kg actual body weight

RADIATION

total-body irradiation

1320 cGy in 11 fractions from day -8 to day -5 or day -9 to day -6 prior to stem cell transplant

Trial Locations (2)

85006

Banner Good Samaritan Medical Center, Phoenix

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER

NCT00589563 - Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer | Biotech Hunter | Biotech Hunter