NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000064

Registered date:17/08/2005

Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with BCR-ABL-Negative Acute Lymphoblastic Leukemia (JALSG ALL202-U)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute lymphoblastic leukemia
Date of first enrollment2002/09/01
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Induction therapy (Week 1-5): MTX, PSL, DEX, VCR, THP-ADR, CPM, L-ASP, Ara-C, HDC. Consolidation therapy (Week 6-9): CPM, THP-ADR, Ara-C, 6MP, MTX, HDC. Sanctuary therapy (Week 10-11): MTX, Ara-C, HDC. Reinduction therapy (Week 12-15): VCR, THP-ADR, CPM, L-ASP, PSL, MTX, Ara-C, HDC. Reconsolidation therapy (Week 16-19): CPM, THP-ADR, Ara-C, 6MP, MTX, HDC. Maintenance therapy (Week 20-25): MTX, 6MP, CPM, THP-ADR, Ara-C, 6MP, HDC. Maintenance therapy (Week 26-29, 46-49, 66-69, 86-89): VCR, CPM , L-ASP, PSL. Maintenance therapy (Week 30-35, 40-45, 50-55, 60-65, 70-75, 80-85, 90-95): MTX, 6MP, Ara-C, HC. Maintenance therapy (Week 36-39, 56-59, 76-79, 96-98): VCR, THP-ADR, L-ASP, PSL.

Outcome(s)

Primary OutcomeDisease-free survival at 3 years
Secondary OutcomeToxicity, the rate of complete remission

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum25years-old
GenderMale and Female
Include criteria(1) Previously untreated BCR-ABL-negative ALL (2) Age between 15 and 24 years (3) Performance status between 0 and 3 (ECOG criteria) (4) 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) (5) Written informed consent to participate the trial
Exclude criteria(1) Uncontrolled active infection (2) Another severe and/or life-threatening disease (3) Positive for HIV antibody and/or HBs antigen tests (4) Another primary malignancy which is clinically active and/or requires medical interventions (5) Pregnant and/or lactating woman (6) Past history of renal failure

Related Information

Contact

public contact
Name Fumihiko Hayakawa
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan Japan
Telephone 052-744-2145
E-mail bun-hy@med.nagoya-u.ac.jp
Affiliation Nagoya University Graduate School of Medicine Department of Hematology and Oncology
scientific contact
Name Tomoki Naoe
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan Japan
Telephone 052-744-2145
E-mail
Affiliation Nagoya University Graduate School of Medicine Department of Hematology and Oncology