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

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

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.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Drug: cyclophosphamide; Radiation: radiation therapy; Drug: methotrexate; Procedure: peripheral blood stem cell transplantation

Detailed Description

OBJECTIVES:

• 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
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 55 and under

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

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

Renal:

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

Cardiovascular:

• No symptomatic cardiac disease

Pulmonary:

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

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow or peripheral blood stem cell transplantation

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• 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

Surgery:

• Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Claudio Anasetti, MD, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 1996
• Primary Completion (Actual): October 1, 2002
• Study Completion (Actual): October 1, 2002

Study Registration Dates

• First Submitted: October 11, 2001
• First Submitted That Met QC Criteria: June 19, 2003
• First Posted (Estimate): June 20, 2003

Study Record Updates

• Last Update Posted (Estimate): May 13, 2010
• Last Update Submitted That Met QC Criteria: May 12, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: secondary acute myeloid leukemia; childhood acute lymphoblastic leukemia in remission; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; adult acute lymphoblastic leukemia in remission; recurrent childhood acute myeloid leukemia; acute undifferentiated leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Cyclophosphamide; Methotrexate
• Other Study ID Numbers: 1099.00; FHCRC-1099.00; NCI-H01-0078; CDR0000068972 (Registry Identifier: PDQ)