UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000065
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

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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 or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



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

Value
https://center6.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