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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

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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)
Region
Japan

Condition
Condition Acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology
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
Medicine
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.)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >
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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoki Naoe
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiko Hayakawa
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/
Email bun-hy@med.nagoya-u.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Japan: Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 17 Day

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. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2002 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2002 Year 08 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 12 Month 01 Day
Date trial data considered complete
2008 Year 02 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 17 Day
Last modified on
2008 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000106

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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