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

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ClinicalTrials.gov Identifier: NCT00005984
Recruitment Status : Terminated (Study terminated as principal investigator [PI] left the university.)
First Posted : January 27, 2003
Last Update Posted : November 29, 2017
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: cyclophosphamide Drug: filgrastim Drug: recombinant interferon alfa Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
Study Start Date : August 2000
Primary Completion Date : September 2005
Study Completion Date : September 2005


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Time to hemopoietic recovery after transplantation
  2. Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples

Secondary Outcome Measures :
  1. Time to initial hospital discharge
  2. Peritransplantation toxicity
  3. Quality of life at various time points
  4. Cause of death

Eligibility Criteria

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005984


Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Catherine M. Verfaillie, MD Masonic Cancer Center, University of Minnesota
More Information

Responsible Party: Catherine Verfaille, MD, Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00005984     History of Changes
Other Study ID Numbers: 1996LS183
UMN-MT-1996-11 ( Other Identifier: Blood and Marrow Transplantation Program )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: September 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
chronic phase myelogenous leukemia
accelerated phase myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Interferons
Interferon-alpha
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic