Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia
Condition: Graft Versus Host Disease; Leukemia; Myelodysplastic Syndromes
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Filgrastim; Cladribine; Cyclosporine; Cytarabine (Ara-C); Fludarabine Phosphate; Idarubicin; Methylprednisolone; Peripheral Blood Stem Cell Transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.; Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.; 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.; 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.; IV over 30 minutes daily on days -6, -5, -4 and -3.; IV Days -6, -5 and -4.; Begins 5 days after infusion and is gradually tapered.; Cell infusion Day 0.
Other intervention name(s): G-CSF; Neupogen; Leustatin; 2-CdA; Sandimmune; CYA; Cyclosporin A; Ara-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride; Fludara; Fludarabine; Idamycin; Depo-Medrol; Medrol; Solu-Medrol; PBSCT; Stem Cell Transplant
Intervention MeSH terms: Cytarabine; Cyclosporine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Fludarabine; Fludarabine phosphate; Idarubicin; Cladribine; Cyclosporins; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; Philadelphia chromosome positive chronic myelogenous leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; graft versus host disease