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

Lymphoblastic Leukemia, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00131053
• Other study ID #: JALSG ALL202-U
• Status: Recruiting
• Phase: Phase 2
• First received: August 15, 2005
• Last updated: November 13, 2008
• Start date: September 2002
• Est. completion date: September 2011

Study information

• Verified date: November 2008
• Source: Japan Adult Leukemia Study Group
• Contact: Fumihiko Hayakawa, MD
• Email: bun-hy[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 24 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Methotrexate

• Prednisolone

• Dexamethasone

• Vincristine

• Pirarubicin

• Cyclophosphamide

• L-asparaginase

• Cytarabine

• Hydrocortisone

• Mercaptopurine

Locations

Country	Name	City	State
Japan	Department of Hematology, Nagoya University Graduate School of Medicine	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Japan Adult Leukemia Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years	No
Secondary	The rate of complete remission		3 years	Yes

External Links

•   The JALSG homepage