Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia</p>

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025545
Recruitment Status : Completed
First Posted : June 20, 2003
Last Update Posted : May 13, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.

PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cyclophosphamide Drug: methotrexate Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.
  • Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.
  • Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
  • Determine the leukemia-free survival of patients treated with this regimen.

OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.

Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.

PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
Study Start Date : March 1996
Actual Primary Completion Date : October 2002
Actual Study Completion Date : October 2002

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • One of the following diagnoses:

    • Primary acute leukemia beyond first remission
    • High-risk acute myelogenous leukemia
    • Acute lymphoblastic leukemia in first remission
  • Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles

    • No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype
  • No leukoencephalopathy



  • 55 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • SGOT no greater than 2 times normal
  • Hepatitis B surface antigen negative
  • No prior hepatitis C


  • No impaired renal function
  • Creatinine less than 2 times normal


  • No symptomatic cardiac disease


  • No active pulmonary disease
  • DLCO at least 60% predicted


  • HIV negative
  • No disease or other malignancy that severely limits life expectancy
  • No severe or life-threatening infection within the past 2 weeks
  • No history of septate fungal infection or disseminated candidiasis


Biologic therapy:

  • No prior bone marrow or peripheral blood stem cell transplantation


  • Not specified

Endocrine therapy:

  • Not specified


  • No prior radiotherapy greater than 3,000 cGy to whole brain
  • No prior radiotherapy of 1,500 cGy to chest or abdomen
  • At least 6 months since prior involved-field radiotherapy to chest or abdomen


  • Not specified

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 identifier (NCT number): NCT00025545

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Claudio Anasetti, MD Fred Hutchinson Cancer Research Center Identifier: NCT00025545     History of Changes
Other Study ID Numbers: 1099.00
CDR0000068972 ( Registry Identifier: PDQ )
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
acute undifferentiated leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors