Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)

Phase 2

• Conditions: Lymphoblastic Leukemia, Acute
• Interventions: Drug: Methotrexate; Drug: Prednisolone; Drug: Dexamethasone; Drug: Vincristine; Drug: Pirarubicin; Drug: Cyclophosphamide; Drug: L-asparaginase; Drug: Cytarabine; Drug: Hydrocortisone; Drug: Mercaptopurine

• Registration Number: NCT00131053
• Lead Sponsor: Japan Adult Leukemia Study Group

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-08-15
• Study First Submitted QC: 2005-08-15
• Study First Posted: 2005-08-17
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-13
• Last Update Posted: 2008-11-14
• Primary Completion: 2011-05
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Dexamethasone	-
A	Pirarubicin	-
A	Cyclophosphamide	-
A	L-asparaginase	-
A	Cytarabine	-
A	Mercaptopurine	-
A	Methotrexate	-
A	Prednisolone	-
A	Vincristine	-
A	Hydrocortisone	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
The rate of complete remission	3 years

Trial Locations

Locations (1)

Department of Hematology, Nagoya University Graduate School of Medicine; 🇯🇵 Nagoya, Japan