Clinical trial NCT00131053: Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Official title: Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoblastic Leukemia, Acute
Keywords: acute lymphoblastic leukemia
newly diagnosed
BCR-ABL-negative
Lead sponsor: Japan Adult Leukemia Study Group
Sponsor class: OTHER
First posted: 2005-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.

Detailed description: 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 therapy.

Eligibility criteria: 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 echocardiographs).
* 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 interventions
* Pregnant and/or lactating women
* Past history of renal failure

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: The rate of complete remission
timeFrame: 3 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Hematology, Nagoya University Graduate School of Medicine
Study officials:
affiliation: Nagoya University
name: Fumihiko Hayakawa, MD
role: STUDY_DIRECTOR
affiliation: Nagoya University
name: Tomoki Naoe, MD
role: STUDY_CHAIR
References: