Unique ID issued by UMIN | C000000064 |
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Receipt number | R000000108 |
Scientific Title | Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with BCR-ABL-Negative Acute Lymphoblastic Leukemia (JALSG ALL202-U) |
Date of disclosure of the study information | 2005/08/17 |
Last modified on | 2011/10/27 11:31:59 |
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with BCR-ABL-Negative Acute Lymphoblastic Leukemia (JALSG ALL202-U)
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with ALL (JALSG ALL202-U)
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with BCR-ABL-Negative Acute Lymphoblastic Leukemia (JALSG ALL202-U)
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients with ALL (JALSG ALL202-U)
Japan |
Acute lymphoblastic leukemia
Hematology and clinical oncology |
Malignancy
YES
The purpose of this study is to investigate efficacy and safety of treating adult ALL patients with an intensive pediatric regimen.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Disease-free survival at 3 years
Toxicity, the rate of complete remission
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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.
15 | years-old | <= |
25 | years-old | > |
Male and Female
(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
(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
120
1st name | |
Middle name | |
Last name | Tomoki Naoe |
Nagoya University Graduate School of Medicine
Department of Hematology and Oncology
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
052-744-2145
1st name | |
Middle name | |
Last name | Fumihiko Hayakawa |
Nagoya University Graduate School of Medicine
Department of Hematology and Oncology
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
052-744-2145
http://www.jalsg.jp/
bun-hy@med.nagoya-u.ac.jp
Japan Adult Leukemia Study Group
Japan: Ministry of Health, Labor and Welfare
Japan
YES
NCT00131053
Clinicaltrials.gov
2005 | Year | 08 | Month | 17 | Day |
Unpublished
No longer recruiting
2002 | Year | 09 | Month | 01 | Day |
2002 | Year | 09 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2005 | Year | 08 | Month | 17 | Day |
2011 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000108
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