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
N/A
55 Years
Both
Leukemia
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Claudio Anasetti, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1099.00
NCT ID:
NCT00025545
Start Date:
March 1996
Completion Date:
October 2002
Related Keywords:
- Leukemia
- 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
- Leukemia
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
