Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia

• Status: Terminated
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Cyclophosphamide; Interferon-alpha; Interferons; Lenograstim

Criteria

Inclusion Criteria:

• Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)

• Philadelphia chromosome positive OR

• BCR/ABL rearrangement

• Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols

• 70 and under

• Performance status:

• Age 65-70 years:

• Karnofsky 80-100%

• Under 65 years:

• Karnofsky 90-100%

• Renal:

• Age 65-70 years:

• Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)

• Under 65 years:

• Not specified

• Cardiovascular:

• Age 65-70 years:

• LVEF at least 45%

• Pulmonary:

• Age 65-70 years:

• If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted

• Normal organ function (excluding bone marrow)

Exclusion Criteria:

• Blast crisis or post blast crisis

• Severe fibrosis defined by bilateral trephine biopsies

• Splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy