UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001519
Receipt number R000001833
Scientific Title Treatment protocol for adult acute lymphocytic leukemia -ALL/ MRD2008-
Date of disclosure of the study information 2008/12/01
Last modified on 2016/05/22 11:10:21

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Basic information

Public title

Treatment protocol for adult acute lymphocytic leukemia
-ALL/ MRD2008-

Acronym

ALL/MRD2008

Scientific Title

Treatment protocol for adult acute lymphocytic leukemia
-ALL/ MRD2008-

Scientific Title:Acronym

ALL/MRD2008

Region

Japan


Condition

Condition

adult acute lymphocytic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We plan the risk-adjusted treatment protocol for adult acute lymphocytic leukemia.
The risks are determined by the MRD status post consolidation treatment.

High-risk patients will proceed to allogeneic hematopoietic stem cell transplantation, while low-risk patients will proceed to maintenance treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

3 years disease-free survival

Key secondary outcomes

5 years disease free survival, CR rate, treatment-related toxicities


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In adult BCR/ABL negative ALL, the indication of allogeneic HSCT will be determined by the MRD status. High-risk patients will proceed to allogeneic HSCT. Low-risk patients will proceed to maintenance treatment which is less toxic than HSCT.

In adult BCR/ABL positive ALL, patients will receive induction therapy combined with imatinib. Every patient will proceed to allogeneic HSCT whenever possible.

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

16 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1. acute lymphoblastic leukemia by WHO classification
2. peroxidase positive rate of the blast cell, 3% are less than it
3. The first time treatment example which does not catch chemotherapy or the radiotherapy
4. The case that is equal to or less than 65 years old more than age 15 years old
5. Performance status 0-2
6. A case without the dangerously ill internal organs disorder
T.Bil equal to or less than 2.0mg/dL, Cr equal to or less than 2.0mg/dL
7. The case that an agreement by the document is provided from a patient on explanation because of final examination contents

Key exclusion criteria

1. B-ALL(L3) of the blast cell cell surface immune globulin positive
2. A case having double cancers
3. A case with an infectious disease having difficulty with control
4. A case with a severe mental disorder
5. The pregnancy or breast-feeding woman
6. the case that the medical attendant judged to be inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Nagafuji

Organization

Kurume University School of Medicine

Division name

Hematology/Oncology

Zip code


Address

67 Asahi-machi, Kurume 830-0011, Japan

TEL

0942-31-7852

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshihiro Miyamoto

Organization

Kyushu University Hospital

Division name

Hematology/Oncology

Zip code


Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5230

Homepage URL


Email

toshmiya@intmed1.med.kyushu-u.ac.jp


Sponsor or person

Institute

Fukuoka Blood & Marrow Transplant Group

Institute

Department

Personal name



Funding Source

Organization

Fukuoka Blood & Marrow Transplant Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 12 Month 01 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

2008 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2016 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 11 Month 21 Day

Last modified on

2016 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name