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Chemotherapy, Filgrastim and Peripheral Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia

This study has been terminated.
(Principal investigator left the university.)
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00005986
First received: July 5, 2000
Last updated: July 13, 2011
Last verified: July 2011
History of Changes

July 5, 2000
July 13, 2011
August 2000
September 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00005986 on ClinicalTrials.gov Archive Site
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Chemotherapy, Filgrastim and Peripheral Stem Cell Transplantation in Patients With Chronic Myelogenous Leukemia
Autologous Transplantation for Chronic Myelogenous Leukemia Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy and filgrastim followed by peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia.

OBJECTIVES:

  • Assess clinical outcomes, survival, and morbidity of transplantation therapy in patients with chronic myelogenous leukemia when treated with high dose chemotherapy and filgrastim (G-CSF) followed by autologous retrovirally transduced peripheral blood stem cell (PBSC) transplantation.
  • Determine whether this priming treatment can increase the fraction of benign Philadelphia chromosome (Ph) negative hematopoietic progenitors in PBSC and reduce the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.
  • Assess whether retroviral transduction of mobilized PBSC progenitors determines the contribution of malignant Ph positive progenitors contaminating the graft to relapse after transplantation in these patients.
  • Determine whether this priming treatment can expand the benign progenitor population in the PBSC collections from these patients.

OUTLINE: In the priming phase, patients receive cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SQ) daily beginning on day 4 and continuing until the completion of leukapheresis. Peripheral blood stem cells (PBSC) are harvested 4-7 times between days 10 and 21 beginning when blood counts recover (CD34+ cells are selected from 2 of these PBSC collections and transduced with the LN NEO virus prior to cryopreservation).

In the transplant phase, patients who have not received prior radiotherapy receive cyclophosphamide IV over 2 hours daily on days -7 and -6 and total body irradiation on days -4 through -1. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.

Patients who have received prior radiotherapy receive oral busulfan every 6 hours on days -10 through -7 and cyclophosphamide IV daily on days -6 through -3. Autologous PBSC and LN NEO transduced CD34+ cells are reinfused on day 0. Patients also receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.

All patients then receive interferon alfa SQ daily until disease progression or unacceptable toxicity.

Patients are followed at 3 weeks; at 3, 6, 9, 12, 18, and 24 months; and then annually thereafter.

PROJECTED ACCRUAL: A total of 4-26 patients will be accrued for this study.
Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Drug: filgrastim
  • Drug: recombinant interferon alfa
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Procedure: radiation therapy
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
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September 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia

    • Philadelphia chromosome positive OR
    • BCR/ABL rearrangement
  • No blast crisis or post blast crisis
  • No moderate to severe fibrosis defined by bilateral trephine biopsies
  • Not eligible for or refused to participate in allogeneic marrow transplant protocols
  • No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 to 65

Performance status:

  • Karnofsky 90-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Normal organ function (except bone marrow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior interferon alfa allowed

Chemotherapy:

  • Prior hydroxyurea allowed
  • At least 2 months since prior busulfan (at time of PBSC harvest)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005986
CDR0000067974, UMN-MT-9507
Not Provided
Catherine Verfaillie, MD, unknown
Masonic Cancer Center, University of Minnesota
Not Provided
Study Chair: Catherine M. Verfaillie, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP