Unique ID issued by UMIN | C000000065 |
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Receipt number | R000000106 |
Scientific Title | Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202) |
Date of disclosure of the study information | 2005/08/17 |
Last modified on | 2008/12/17 23:07:45 |
Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202)
Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive ALL (JALSG Ph+ALL202)
Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202)
Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive ALL (JALSG Ph+ALL202)
Japan |
Acute lymphoblastic leukemia
Hematology and clinical oncology |
Malignancy
YES
The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
The rate of complete remission
The duration of remission, overall survival at one year, toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Remission induction therapy: Cyclophosphamide (CPM) 1200 mg/sqm (*800 mg/sqm), 3hr-div, day 1. Daunorubicin (DNR) 60 mg/sqm (*30 mg/sqm), 1hr-div, day 1,2,3. Vincristine (VCR) 1.3 mg/sqm (max. 2 mg), bolus iv, day 1,8,15,22. Prednisolone (PSL) 60 mg/sqm, po, day 1-21 (*day1-7). Imatinib 600 mg/body, po, day 8-63. Methotrexate (MTX) 15 mg/body, Cytarabine (Ara-C) 40 mg/body, Dexamethasone (DEX) 4 mg/body, IT, day 29. Consolidation therapy: C1: MTX 1 g/sqm, 24hr-div, day 1. Ara-C 2 g/sqm(*1 g/sqm), 3hr-div q12h, day 2,3. Methylprednisolone (mPSL) 50 mg/body, bolus iv q12h, day 1-3. MTX 15 mg/body, Ara-C 40 mg/body, DEX 4 mg/body, IT, day 1. C2: Imatinib 600mg/body, po, day 1-28. MTX 15 mg/body, Ara-C 40 mg/body, DEX 4 mg/body, IT, day 1. (C1 and C2 are alternated for 4 cycles each.) Maintenance therapy: Imatinib 600mg/body, po, day 1-28. VCR 1.3 mg/sqm (max. 2 mg), bolus iv, day 1. PSL 60 mg/sqm, po, day 1-5. (Maintenance therapy is administered every 4 weeks up to 2 years from the date of complete remission.) (*In case of patients aged 60 or over.)
15 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Previously untreated BCR-ABL-positive ALL (2) Age between 15 and 64 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
100
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://www2.hama-med.ac.jp/w4a/jalsg/
bun-hy@med.nagoya-u.ac.jp
Japan Adult Leukemia Study Group
Japan: Ministry of Health, Labor and Welfare
Japan
YES
NCT00130195
Clinicaltrials.gov
2005 | Year | 08 | Month | 17 | Day |
Partially published
http://www.jco.org/cgi/content/full/24/3/460
Remission induction therapy resulted in complete remission (CR) in 77 patients (96.2%), resistant disease in one patient, and early death in two patients, as well as polymerase chain reaction negativity of bone marrow in 71.3%. The profile and incidence of severe toxicity were not different from those associated with our historic chemotherapy-alone regimen. Relapse occurred in 20 patients after median CR duration of 5.2 months. Allogeneic hematopoietic stem-cell transplantation (HSCT) was performed for 49 patients, 39 of whom underwent transplantation during their first CR. The 1-year event-free and overall survival (OS) rates were estimated to be 60.0%, and 76.1%, respectively, which were significantly better than those for our historic controls treated with chemotherapy alone (P < .0001 for both). Among the current trial patients, the probability for OS at 1 year was 73.3% for those who underwent allogeneic HSCT, and 84.8% for those who did not.
Completed
2002 | Year | 06 | Month | 17 | Day |
2002 | Year | 08 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 02 | Month | 01 | Day |
2008 | Year | 05 | Month | 01 | Day |
2005 | Year | 08 | Month | 17 | Day |
2008 | Year | 12 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000106
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