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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 1, 1995

Primary Completion Date

December 31, 2002

Study Completion Date

December 31, 2002

Conditions
Leukemia
Interventions
BIOLOGICAL

Filgrastim

Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.

DRUG

Busulfan

Administered orally every 6 hours on consecutive days -6 through -4.

DRUG

Cyclophosphamide

Given intravenously (IV) over 1 hour on consecutive days -3 and -2.

DRUG

Cyclosporine

Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.

DRUG

Decitabine (DAC)

IV over 4 hours on days -8 and -7.

DRUG

Methotrexate

Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.

DRUG

Methylprednisolone

Given according to clinical grade of GVHD procedures.

DRUG

Tacrolimus

IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.

PROCEDURE

Allogeneic Bone Marrow Transplantation

Infusion of stem cells on Day 0.

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Stem cell infusion on 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

NCT00002831 - Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia | Biotech Hunter | Biotech Hunter