UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013540
Receipt No. R000015823
Scientific Title A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Date of disclosure of the study information 2014/03/28
Last modified on 2016/04/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Acronym A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Scientific Title A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Scientific Title:Acronym A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
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 To study the efficacy and safety of CNS prophylaxis (standard R-CHOP, intrathecal methotrexate, and high-dose methotrexate) in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year CNS relapse rate
Key secondary outcomes Response rate, Relapse-free survival, 2-year survival rate, Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 R-CHOP
High-dose methotrexate
Intrathecal methotrexate
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. Histologically confirmed diffuse large B-cell lymphoma
2. High or high-intermediate IPI risk and stage III or IV
3. Patients aged >=20 years
4. Adequate organ function as follows;
#1 Absolute neutrophil count >= 1000/mm3
#2 Platelet count >= 100,000/mm3
#3 Estimated EGFR >= 50
#4 AST and ALT levels <= 3 times the upper limit of the normal range
#5 SpO2 >= 95%
#6 Normal ECG
#7 (If echocardiogram is done)
Left ventricular ejection fraction > 50%
#8 Karnofsky Performance Status >= 40
5. Patients who have at least one measurable lesion, or evaluable disease if there is no measurable lesion.
Measurable lesion can be accurately measured in two dimensions orthogonal with each other by CT scan.
Malignant lymph nodes are to be considered pathologically enlarged and measurable, a lymph node must be >=15mm in long axis or >=10mm in short axis when assessed by CT scan.
Extranodal lesions must be accurately measured in at least one dimension as >=10mm by CT scan (CT scan slice thickness is no greater than 5mm; when CT scan have slice thickness >5mm, the minimum size should be twice the slice thickness).
Evaluable disease is non-measurable lesions but can be confirmed as lymphoma by CT, MRI, PET or endoscopy.
6. Written informed consent
Key exclusion criteria 1. Primary CNS lymphoma (include intraocular lymphoma) or lymphoma with cns involvement on CT and/or MRI, or CSF examination on admission
2. Intravascular lymphoma, primary effusion lymphoma, mediastinal large B-cell lymphoma
3. Primary testicular lymphoma
4. Patients with peripheral bood involvement of lymphoma on admission
5. Prior treatment for lymphoma except lymph node biopsy and local radiation therapy
6. Presence of fluid in the third space (e.g. pleural effusions)
7. Patients with pre-existing renal insufficiency
8. Patients with another active malignancy
9. Patients with serious complications (malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months, uncontrolled hyperglycemia, pulmonary fibrosis, interstitial pneumonia, etc)
10. Severe psychosis
11. Presence of uncontrollable active infection
12. Patients with allergy to drug used for conditioning regimen
13. Positive for HIV antibody, HCV antibody or HTLV-1 antibody
14. HBs antigen positive patients judged unfeasible to participate in this protocol in spite of the administration of antiviral drugs
15. Patients who are pregnant or lactating
16. Without any written consent from patients
17. Inadequate patients to enroll judged by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Nagate
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL 06-6879-3871
Email nagate@bldon.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Nagate
Organization Osaka University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL 06-6879-3871
Homepage URL
Email nagate@bldon.med.osaka-u.ac.jp

Sponsor
Institute Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Institute
Department

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 大阪大学医学部附属病院(大阪府)
府立成人病センター(大阪府)
NTT西日本大阪病院(大阪府)
県立西宮病院(兵庫県)
大手前病院(大阪府)
市立芦屋病院(兵庫県)
市立池田病院(大阪府)
市立伊丹病院(兵庫県)
市立堺病院(大阪府)
市立吹田病院(大阪府)
市立豊中病院(大阪府)
住友病院(大阪府)
日生病院(大阪府)
市立箕面病院(大阪府)
りんくう総合医療センター(大阪府)
八尾市立病院(大阪府)
関西労災病院(兵庫県)
国立病院大阪医療センター(大阪府)
医療法人 川崎病院(兵庫県)
川西市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 28 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 Terminated
Date of protocol fixation
2014 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
2015 Year 06 Month 09 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 27 Day
Last modified on
2016 Year 04 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015823

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.