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HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA


Phase 2
1 Year
19 Years
Open (Enrolling)
Both
Leukemia

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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 CenterOmaha, Nebraska  68198-3330