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

Leukemia Clinical Trial

Official title:

Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005984
• Other study ID #: 1996LS183
• Secondary ID: UMN-MT-1996-11
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: November 27, 2017
• Start date: August 2000
• Est. completion date: September 2005

Study information

• Verified date: September 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid

Intervention

Drug:
• cyclophosphamide
intravenously over 2 hours on day 1 and on days -7 and -6
• filgrastim
filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover
• recombinant interferon alfa
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression

Procedure:
• peripheral blood stem cell transplantation
Patients receive the PBSC transplantation on day 0.
• radiation therapy
total body irradiation twice a day on days -4 through -1

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to hemopoietic recovery after transplantation
Primary	Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples
Secondary	Time to initial hospital discharge
Secondary	Peritransplantation toxicity
Secondary	Quality of life at various time points
Secondary	Cause of death