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

University of Minnesota (UMN)

Status and phase

Terminated

Phase 2

Conditions

Leukemia

Treatments

Drug: recombinant interferon alfa

Procedure: radiation therapy

Procedure: peripheral blood stem cell transplantation

Drug: cyclophosphamide

Drug: filgrastim

Study type

Interventional

Funder types

Other

Identifiers

NCT00005984

UMN-MT-1996-11 (Other Identifier)

1996LS183

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

PROJECTED ACCRUAL: Not specified

Enrollment

22 patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

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