UMIN-CTR Clinical Trial

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

Diffuse large B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

2-year CNS relapse rate

Key secondary outcomes

Response rate, Relapse-free survival, 2-year survival rate, Safety

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

03

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

03

Month

27

Day

Last modified on

2016

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=R000015823