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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000065 |
Receipt No. | 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 |
Basic information | ||
Public title | Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202) | |
Acronym | Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive ALL (JALSG Ph+ALL202) | |
Scientific Title | Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia (JALSG Ph+ALL202) | |
Scientific Title:Acronym | Phase 2 study of imatinib-combined chemotherapy for newly diagnosed BCR-ABL-positive ALL (JALSG Ph+ALL202) | |
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Condition | ||
Condition | Acute lymphoblastic leukemia | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | The rate of complete remission |
Key secondary outcomes | The duration of remission, overall survival at one year, toxicity |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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.) | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | (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 | |||
Key exclusion 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 | |||
Target sample size | 100 |
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Name of lead principal investigator |
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Organization | Nagoya University Graduate School of Medicine | ||||||
Division name | Department of Hematology and Oncology | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan | ||||||
TEL | 052-744-2145 | ||||||
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Organization | Nagoya University Graduate School of Medicine | ||||||
Division name | Department of Hematology and Oncology | ||||||
Zip code | |||||||
Address | 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan | ||||||
TEL | 052-744-2145 | ||||||
Homepage URL | http://www2.hama-med.ac.jp/w4a/jalsg/ | ||||||
bun-hy@med.nagoya-u.ac.jp |
Sponsor | |
Institute | Japan Adult Leukemia Study Group |
Institute | |
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Funding Source | |
Organization | Japan: Ministry of Health, Labor and Welfare |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT00130195 |
Org. issuing International ID_1 | Clinicaltrials.gov |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
URL related to results and publications | http://www.jco.org/cgi/content/full/24/3/460 |
Number of participants that the trial has enrolled | |
Results | 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. |
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Recruitment status | Completed | ||||||
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000106 |
Research Plan | |
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