UMIN-CTR Clinical Trial

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
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Research case data
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