UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022048
Receipt number R000025413
Scientific Title The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT
Date of disclosure of the study information 2016/04/25
Last modified on 2021/10/29 12:29:28

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Basic information

Public title

The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT

Acronym

Chiba AFO-01 study

Scientific Title

The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT

Scientific Title:Acronym

Chiba AFO-01 study

Region

Japan


Condition

Condition

Air flow obstruction after allogeneic SCT

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in patinets with AFO after allogeneic SCT

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The prevention rate of decreasing respiratory function of the triplet combination treatment in AFO patinets

Key secondary outcomes

Efficacy:
1) incidence of AFO in allogeneic stem cell ytansplant recipients
2) the rate of symptom improvement after intervention with triplet combination therapy
3) the rate of the detection of radiologic abnormality, and improvement
4) the correlation between the occurrence of AFO and chronic GVHD
5) OS, NRM, relapse rate
6) the rate of intervention of immunosuppressant
7) QOL assessment by CATS scoring
Safety:
1) adverse events dueing the treatment
2) incidence of infectious episode


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients who diagnosed as AFO start the combination treatment, includind butesonid/formoterol fumarate, clarjthromycin, and monterkast, immediately. If feasible, continue the triplet combination therapy for one year after diagonosis of AFO.

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. The patient who receive the 1st allogeneic stem cell transplantation
2. The patient who can examine the pulmonary function tests.
3. PS (ECOG), 0-2
4. The patient who has no exceptionable organ problems
1) serum ALT/AST concentrations:150 IU/L and under
2) total bilirubin: 3mg/dL and under
3) CCr:40ml/min or over (by C-G)
4) arterial blood oxygen saturation or SpO2 in room air:94% or over
5. Written informed consent

Key exclusion criteria

1. Known history of intolerance or allergy to any triplet component.
2. The patient who has past history of asthma and had attack within one year.
3. The patient who has already been treated with the triplet combination.
4. The patient who has active infection
5. The patient who has mental disability requiring treatment
6. The patient who has severe thromboembolism, including myocardial infarction, cerebral infarction, and cardiovascular complications.
7. The patient who has uncontrollable diabetes mellitus and metabolic disease
8. The patient who has other malignancy requiring anticancer treatment
9. Pregnancy or nursing.
10. At the time of enrollment as judged by the enrolling investigator would interfere
with the subjects ability to comply with the study requirements

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Emiko
Middle name
Last name Sakaida

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code

2608677

Address

1-8-1, inohana, Chuo-ku, Chiba

TEL

043-222-7171

Email

chiaki-nakaseko@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Emiko
Middle name
Last name Sakaida

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code

2608677

Address

1-8-1, inohana, Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

esakaida@faculty.chiba-u.jp


Sponsor or person

Institute

Department of Hematology, Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Hematology, Chiba University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

1-8-1, inohana, Chuo-ku, Chiba

Tel

043-222-7171

Email

esakaida@faculty.chiba-u.jp


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

千葉大学病院、青葉病院、成田赤十字病院、旭中央病院


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 25 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

85

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

2016 Year 01 Month 28 Day

Date of IRB

2016 Year 06 Month 19 Day

Anticipated trial start date

2016 Year 06 Month 20 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete

2021 Year 11 Month 30 Day

Date analysis concluded

2022 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 25 Day

Last modified on

2021 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025413


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name