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

Stopped early · Phase 2

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT00005984

Run by

Masonic Cancer Center, University of Minnesota

People needed

22

Starts

2000-08-01

Expected to finish

2005-09-01

Last updated by the study team

2017-11-29

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.