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


Phase 2
N/A
70 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to hemopoietic recovery after transplantation

Safety Issue:

No

Principal Investigator

Catherine M. Verfaillie, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

1996LS183

NCT ID:

NCT00005984

Start Date:

August 2000

Completion Date:

September 2005

Related Keywords:

  • Leukemia
  • chronic phase myelogenous leukemia
  • accelerated phase myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455