UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031459
Receipt number R000035786
Scientific Title Phase II study of safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk diffuse large B-cell lymphoma
Date of disclosure of the study information 2018/03/01
Last modified on 2021/04/02 12:57:40

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Basic information

Public title

Phase II study of safety and efficacy of
alternating R-CHOP and R-HDMA therapy in
high-risk diffuse large B-cell lymphoma

Acronym

Safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk DLBCL

Scientific Title

Phase II study of safety and efficacy of
alternating R-CHOP and R-HDMA therapy in
high-risk diffuse large B-cell lymphoma

Scientific Title:Acronym

Safety and efficacy of alternating R-CHOP and R-HDMA therapy in high-risk DLBCL

Region

Japan


Condition

Condition

diffuse large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate efficacy of alternating R-CHOP and R-HDMA therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

2-year progression-free survival rate

Key secondary outcomes

2-year overall survival rate
Response rate
Adverse event
Completion rate of protocol treatment
Duration of therapy


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

8 courses of alternating R-CHOP and R-HDMA therapy

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 Histologically confirmed DLBCL
2 No previous chemotherapy
3 Evaluable disease
4 Confirmed to be CD20-positive lymphoma by flowcytometry or immunohistochemistry
5 Age: between 16 and 70
6 PS scale: between 0 and 2
7 Revised IPI; poor
8 No organ dysfunction; leukocyte count more than 2000/mm3, neutrophil count more thhan 1000/mm3, platelet count more than 10000/mm3, AST and ALT less than 150IU/L, total bilirubin less than 2.0 mg/dl, serum creatinine less than 2.0 mg/dl, SpO2 more than 93% (room air), normal ECG.
9 Obtaining written informed consent.

Key exclusion criteria

1 Involvement of central nervous system
2 HBs antigen positive
3 HCV antibody positive
4 HIV antibody positive
5 Active synchronous malignancy
6 Patients who are pregnant, lactating, or possibly pregnant
7 Patients who receive steroid therapy for other diseases
8 Patients with uncontrolled infection
9 Severe allergy to drugs used in this study
10Patients who the researcher judged inappropriate as the subject

Target sample size

26


Research contact person

Name of lead principal investigator

1st name Takehiko
Middle name
Last name Mori

Organization

Keio University School of Medicine

Division name

Hematology Division

Zip code

160-0016

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

tmori@a3.keio.jp


Public contact

Name of contact person

1st name Kota
Middle name
Last name Mizuno

Organization

Keio University School of Medicine

Division name

Hematology Division

Zip code

160-0016

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL


Email

kota10@keio.jp


Sponsor or person

Institute

Division of Hematology, Keio 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

Keio University School of Medicine Ethics Review Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 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

5

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

Terminated

Date of protocol fixation

2017 Year 09 Month 11 Day

Date of IRB

2018 Year 02 Month 26 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2021 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 24 Day

Last modified on

2021 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name