Unique ID issued by UMIN | UMIN000013540 |
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Receipt number | 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 00:50:13 |
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.
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.
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.
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.
Japan |
Diffuse large B-cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
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.
Efficacy
Exploratory
Phase II
2-year CNS relapse rate
Response rate, Relapse-free survival, 2-year survival rate, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
R-CHOP
High-dose methotrexate
Intrathecal methotrexate
20 | years-old | <= |
Not applicable |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Yasuhiro Nagate |
Osaka University Graduate School of Medicine
Department of Hematology and Oncology
2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
06-6879-3871
nagate@bldon.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yasuhiro Nagate |
Osaka University Graduate School of Medicine
Department of Hematology and Oncology
2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
06-6879-3871
nagate@bldon.med.osaka-u.ac.jp
Department of Hematology and Oncology, Osaka University Graduate School of Medicine
None
Self funding
NO
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)
2014 | Year | 03 | Month | 28 | Day |
Unpublished
Terminated
2014 | Year | 03 | Month | 13 | Day |
2014 | Year | 03 | Month | 28 | Day |
2015 | Year | 06 | Month | 09 | Day |
2014 | Year | 03 | Month | 27 | Day |
2016 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015823
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