Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia

Launched by UNIVERSITY OF NEBRASKA · Sep 17, 2003

Keywords

ClinConnect Summary

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 c...

Gender

ALL

Eligibility 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

Trial Officials