Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

October 31, 1994

Primary Completion Date

April 30, 2002

Study Completion Date

April 30, 2002

Conditions
Graft Versus Host DiseaseLeukemiaMyelodysplastic Syndromes
Interventions
BIOLOGICAL

Filgrastim

Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.

DRUG

Cladribine

Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.

DRUG

Cyclosporine

For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.

DRUG

Cytarabine (Ara-C)

Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.

DRUG

Fludarabine Phosphate

IV over 30 minutes daily on days -6, -5, -4 and -3.

DRUG

Idarubicin

IV Days -6, -5 and -4.

DRUG

Methylprednisolone

Begins 5 days after infusion and is gradually tapered.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Cell infusion Day 0.

Trial Locations (1)

77030

University of Texas - MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT00002833 - Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia | Biotech Hunter | Biotech Hunter