NCT00002833

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

Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.

Detailed description

OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable. OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is gradually tapered. PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.

Conditions

• Graft Versus Host Disease
• Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1994-10-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2004-07-30
• Last updated: 2012-07-30

Locations

1 site across 1 country: United States