HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
1 Year
19 Years
Both
Leukemia
Trial Information
HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
OBJECTIVES:
- Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation
for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and
cyclophosphamide in children with relapsed acute lymphocytic leukemia.
- Determine the dose effect of autologous PBSC on engraftment in this patient population.
OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours
on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are
harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units,
and CD34+ cells.
Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine
IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV
on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or
sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo
radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia
undergo craniospinal irradiation before transplantation.
Patients are followed at 100 days, 6 months, and 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoblastic leukemia
- Pathologic evidence of relapse in marrow, CNS, or testes
- In second or later complete remission
- Ineligible for allogeneic transplantation:
- No suitable allogeneic donor (sibling or family donor or unrelated donor with no
more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR
- Ineligible for preparative regimen including total-body irradiation
- Peripheral blood stem cell collection feasible:
- Patient size generally at least 8 kg
- Able to place central venous catheter
- Patient cooperative
PATIENT CHARACTERISTICS:
Age:
- 1 to 19
Performance status:
- Not moribund
Life expectancy:
- No severe limits from disease other than leukemia
Hepatic:
- Bilirubin no greater than 3 times normal for age
- AST and/or GGT no greater than 3 times normal for age
- No evidence of hepatic synthetic dysfunction
Renal:
- GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance
Cardiovascular:
- Cardiac contractility normal on echocardiogram
Pulmonary:
- FVC and FEV_1 with or without DLCO at least 50% predicted
Other:
- No significant active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Bruce G. Gordon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Nebraska
Authority:
United States: Federal Government
Study ID:
CDR0000064114
NCT ID:
NCT00002638
Start Date:
March 1995
Completion Date:
Related Keywords:
- Leukemia
- recurrent childhood acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
