UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000063
Receipt number R000000109
Scientific Title Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)
Date of disclosure of the study information 2005/08/17
Last modified on 2011/10/27 11:31:30

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Basic information

Public title

Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)

Acronym

Randomized Controlled Trial to Test Efficacy of High-Dose MTX for ALL (JALSG ALL202-O)

Scientific Title

Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults (JALSG ALL202-O)

Scientific Title:Acronym

Randomized Controlled Trial to Test Efficacy of High-Dose MTX for ALL (JALSG ALL202-O)

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 investigate clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL negative ALL.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Disease-free survival at 3 years

Key secondary outcomes

Toxicity, the rate of complete remission


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 3000 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.

Interventions/Control_2

Induction therapy: CPM, DNR, VCR, PSL, L-ASP. Consolidation therapy 1: Ara-C, ETP, DEX, MTX. Consolidation therapy 2: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Consolidation therapy 3: VCR, ADR, DEX, CPM, 6MP, Ara-C, MTX, DEX. Consolidation therapy 4: Ara-C, ETP, DEX, MTX. Consolidation therapy 5: MTX, VCR, 6MP, DEX. * MTX 500 mg/sqm, 24h-div, day1,15. Maintenance therapy VCR, PSL, MTX, 6MP.

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

25 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Previously untreated BCR-ABL-negative ALL (2) Age between 25 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

240


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://www.jalsg.jp/

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

NCT00131027

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

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

No longer recruiting

Date of protocol fixation

2002 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2002 Year 09 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2012 Year 03 Month 01 Day

Date analysis concluded

2012 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 17 Day

Last modified on

2011 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000109


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name