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Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia

Phase 2
15 Years
24 Years
Open (Enrolling)
Lymphoblastic Leukemia, Acute

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Trial Information

Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia

The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts
with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to
several differences between adults and children with respect to biological characteristics
of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been
reported that adolescent ALL patients who were treated according to the pediatric protocol
had a significantly better survival than those who were treated according to the adult
protocol, indicating that the difference of treatment may be of considerable importance. To
test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2
study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen
which was used by the Japan Association of Childhood Leukemia Study. Those who are positive
for BCR-ABL can participate in a separate protocol. The regimen is especially characterized
by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance

Inclusion Criteria:

- Previously untreated BCR-ABL-negative ALL

- Age between 15 and 24 years

- Performance status between 0 and 3 (ECOG criteria)

- Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL); kidneys (serum
creatinine level < 2.0 mg/dL); and heart (left ventricular ejection fraction greater
than 50% and no severe abnormalities detected on electrocardiograms and

- Written informed consent to participate in the trial

Exclusion Criteria:

- Uncontrolled active infection

- Another severe and/or life-threatening disease

- Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests

- Another primary malignancy which is clinically active and/or requires medical

- Pregnant and/or lactating women

- Past history of renal failure

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Fumihiko Hayakawa, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nagoya University Graduate School of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2002

Completion Date:

September 2011

Related Keywords:

  • Lymphoblastic Leukemia, Acute
  • acute lymphoblastic leukemia
  • newly diagnosed
  • BCR-ABL-negative
  • Acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Acute Disease