UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005662
Receipt number R000006693
Scientific Title Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome
Date of disclosure of the study information 2011/05/30
Last modified on 2018/07/27 14:45:34

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Basic information

Public title

Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Acronym

Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Scientific Title

Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Scientific Title:Acronym

Efficacy and safety of a 5-day regimen of azacitidine in patients with low-risk myelodysplastic syndrome

Region

Japan


Condition

Condition

low-risk myelodysplastic syndrome

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aime of this study is to analyze the efficacy and safety of 5-day regimen of azacitidine in patients with low-risk MDS (RA, RARS) and to evaluate the changes of various clinical markers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

hematological improvement

Key secondary outcomes

1. hematological remission
2. transfusion dependency
3. hematological improvement in each chromosomal karyotype
4. progression stage (WT1)
5. continuity of therapy
6. adverse events


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

The dosage is 75mg/m2 of azacitidine by subcutaneous injection or intravenous infusion for 10 minutes once daily for 7 days every four weeks.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients with low risk MDS (RA, RARS) according to FAB classification and is considered by investigator to be adequate for this study, meeting at least one of three following criteria.
i) a packed red blood cell transfusion history in 3 months (12 weeks) prior to the enrollment
ii) platelet count less than 50,000/mm3 or clinically meaningful bleeding symptoms
iii) neutrophil count less than 1,000/mm3 and increased susceptibility to infection (requiring use of antibiotics)
2. Patients with a life expectancy of at least 3 months at the time of enrollment
3. Patients with no prior administration of azacitidine-based treatment (Chemotherapy, HSCT, Lenalidomide, Imuunosuppressive therapy, Anabolic steroids therapy, Iron-chelation therapy, Vitamin D and Vitamin K are allowed)
4. Age: 20 years and over
5. Patients who is not planned for allo-HSCT.
6. Patients with ECOG performance status of 0-2
7. Patients with clinically adequate hepatic, renal and heart function defined as follows
i) Serum total bilirubin less than 2.0 mg/dl
ii) Serum creatinine less than 2.0 mg/dl
iii) PaO2 more than 60 Torr or SaO2 more than 93% while breathing room air.
iv) no severe ECG abnormalities.
8. Patients who can be hospitalized during at least 1st cycle.
9. Patients who has given a written informed consent for this study (including contraception).

Key exclusion criteria

1. Patients with simultaneous multiple cancers.
2. Patients with history of hyper- sensitivity to mannitol
3. Patients with poorly-controlled infection requiring intensive care with antibiotics and antifungals.
4. Patients with poorly-controlled diabetes.
5. Patients with severe psychiatric disorder.
6. Pregnant or lactating females.
7. Patients with positive serology for HBs antigen, HCV antibody or HIV antibody.
8. Patients who is deemed as ineligible for this study by investigator.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Matsuda, MD, PhD

Organization

PL General Hospital

Division name

Department of Hematology

Zip code


Address

2204 Shindo, Tondabayashi, Osaka 584-8585

TEL

0721-23-7805

Email



Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Matsuda, MD, PhD

Organization

PL General Hospital

Division name

Department of Hematology

Zip code


Address

2204 Shindo, Tondabayashi, Osaka 584-8585

TEL

0721-23-7805

Homepage URL


Email

matsuda@plhospital.or.jp


Sponsor or person

Institute

Department of Hematology, Kinki University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

2011 Year 05 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 05 Month 31 Day

Date analysis concluded

2018 Year 04 Month 07 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 27 Day

Last modified on

2018 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006693