UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004495
Receipt number R000005316
Scientific Title Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy
Date of disclosure of the study information 2010/11/03
Last modified on 2013/12/03 17:44:01

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Basic information

Public title

Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy

Acronym

Investigation of the efficacy of aprepitant and its drug interaction with prednisolone in (R-)CHOP therapy

Scientific Title

Investigation of the efficacy of an antiemetic, aprepitant and its drug interaction with prednisolone in CHOP or R-CHOP therapy

Scientific Title:Acronym

Investigation of the efficacy of aprepitant and its drug interaction with prednisolone in (R-)CHOP therapy

Region

Japan


Condition

Condition

non-Hodgkin lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate drug interaction of aprepitant and prednisolone by measurement of blood prednisolone concentration in combination with or without aprepitant in the patients treated by CHOP or R-CHOP, which is highly emetic chemotherapy and contains prednisolone.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Pharmacokinetics of prednisolone (and its metabolites). They are measured from day 3 to day 4 in the first (without aprepitant) and the second (with aprepitant) courses of (R-) CHOP therapy in every patient.

Key secondary outcomes



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

Antiemesis therapy with granisetron is performed on day 1 in the 1st course of (R-) CHOP therapy. In the 2nd course, 125 mg of aprepitant per os in a single administration, and 60 mg per os in a single administration on day 2 and 3, are added to the antiemesis therapy with granisetron.

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

A patient with non-Hodgkin lymphoma who is to be treated with (R-)CHOP therapy for the first time. Performance status (ECOG) grade 0 - 2, with estimated life expectancy of 3 months or more, and with sufficient blood count, liver and renal function.

Key exclusion criteria

The use of drugs which affect metabolism of aprepitant and prednisolone, the use of antiemetics or drugs with antiemetic effect which is not prescribed within 48 hours before (R-)CHOP initiation, irradiation to the abdomen or pelvis within 6 days before (R-)CHOP initiation, the onset of vomitting or dry vomiting within 24 hours before (R-)CHOP initiation, symptomatic brain metastasis, beeing pregnant or lactating, the possibility of pregnancy, using oral contraceptive, previous use of aprepitant, diabetes mellitus with drug treatment, HbA1c >= 6.5 %, fasting blood glucose >= 126 mg/dl, psychiatric disorder, a patients who is considered as ineligible by the attending doctor.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Chiba

Organization

University of Tsukuba

Division name

Division of Hematology

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Okoshi

Organization

University of Tsukuba

Division name

Division of Hematology

Zip code


Address


TEL

029-853-3127

Homepage URL


Email

yokoshi@md.tsukuba.ac.jp


Sponsor or person

Institute

Division of Hematology, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Division of Hematology, University of Tsukuba

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

筑波大学附属病院(茨城県)


Other administrative information

Date of disclosure of the study information

2010 Year 11 Month 03 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

2010 Year 10 Month 14 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 01 Day

Last modified on

2013 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name