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

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

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.

Study Overview

Detailed 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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with CML
Patients treated for chronic accelerated phase and/or chronic myelogenous leukemia (CML)
intravenously over 2 hours on day 1 and on days -7 and -6
Other Names:
  • Cytoxan
  • Endoxan
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
Other Names:
  • NEUPOGEN®
Beginning on Day 1, subcutaneous (SQ) daily administration in the absence of unacceptable toxicity or disease progression
Other Names:
  • INTRON® A
Patients receive the PBSC transplantation on day 0.
Other Names:
  • bone marrow transplant
total body irradiation twice a day on days -4 through -1
Other Names:
  • irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to hemopoietic recovery after transplantation
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples

Secondary Outcome Measures

Outcome Measure
Cause of death
Time to initial hospital discharge
Peritransplantation toxicity
Quality of life at various time points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Catherine M. Verfaillie, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

September 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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