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Completed

NCT Number: NCT00025545

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

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.

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Key information

Age range

Up to 55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

methotrexate

Drug

peripheral blood stem cell transplantation

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
1996
Primary completion
2002
Study completion
2002
First posted
Jun 20, 2003
Registry last updated
May 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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