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

NCT ID: NCT00131053

Last Updated: 2008-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lymphoblastic Leukemia, Acute

Keywords

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acute lymphoblastic leukemia newly diagnosed BCR-ABL-negative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Pirarubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

L-asparaginase

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Hydrocortisone

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

Interventions

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Methotrexate

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Pirarubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

L-asparaginase

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Hydrocortisone

Intervention Type DRUG

Mercaptopurine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Adult Leukemia Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Fumihiko Hayakawa, MD

Role: STUDY_DIRECTOR

Nagoya University

Tomoki Naoe, MD

Role: STUDY_CHAIR

Nagoya University

Locations

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Department of Hematology, Nagoya University Graduate School of Medicine

Nagoya, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Fumihiko Hayakawa, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fumihiko Hayakawa, MD

Role: primary

Related Links

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http://www.jalsg.jp/

The JALSG homepage

Other Identifiers

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JALSG ALL202-U

Identifier Type: -

Identifier Source: org_study_id