UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005707
Receipt No. R000006733
Scientific Title Phase II study of R-CHOP and R-high-dose MTX therapy for untreated intravascular large B-cell lymphoma (PRIMEUR-IVL)
Date of disclosure of the study information 2011/06/03
Last modified on 2020/06/07 (Ver. 20)

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Basic information
Public title Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBCL (PRIMEUR-IVL)
Acronym Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBCL
Scientific Title Phase II study of R-CHOP and R-high-dose MTX therapy for untreated intravascular large B-cell lymphoma (PRIMEUR-IVL)
Scientific Title:Acronym Phase II study of R-CHOP and R-high-dose MTX therapy for IVLBCL
Region
Japan

Condition
Condition Intravascular large B-cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase II study evaluating safety and efficacy of R-CHOP combined with R-high dose MTX and IT for patients with newly diagnosed intravascular large B-cell lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year progression free survival rate; 2-year PFS
Key secondary outcomes complete response rate; %CR, 2-year overall survival rate; 2-year OS, 2-year CNS recurrence rate, adverse event, patterns of disease progression

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 Three cycles of R-CHOP followed by 2 cycles of R-HDMTX and 3 additional cycles of R-CHOP. Four doses of IT is administered during R-CHOP phase.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histologically diagnosed as intravascular large B-cell lymphoma
2. CD20-positive on immunohistochemistry and/or flowcytometry
3. Age between 20 and 79 year-old
4. ECOG performance status 0 to 3. PS 4 is eligible if improved PS 3 or better after corticosteroid monotherapy
5. No prior chemotherapy or monoclonal antibody therapy
6. Adequate organ functions including bone marrow, liver, kidney, cardiac and lung functions.
a) No active hepatitis or liver chirrhosis
b) Serum bilirubin less than 3mg/dl
c) Serum creatinine less than 2mg/dl
d) Left ventricular ejection fraction 50% or better
e) No ischemic heart disease requiring treatment, cardiomyopahty, heart failure and arrhythmia treated with anti-arrhythmics
f) SpO2 92% or better
g) WBC equal to or more than 3,000/ul, or ANC equal to or more than 1000/ul, and platelet equal to or more than 10 x 104/ul. Leukocytopenia or thrombocytopenia due to bone marrow invasion or hemophagocytic syndrome is permitted.
7. written informed consent
Key exclusion criteria 1. De novo DLBCL
2. CNS involvement on CT and/or MRI, or CSF examination
3. Glaucoma requiring treatment
4. Diabetes mellitus requiring insulin treatment
5. Hypertension
6. Positive on HBsAg. HBV-DNA positive if HBsAb and/or HBcAb are positive
7. Positive on HCV Ab
8. Positive on HIV Ab
9. Interstitial pneumonitis, pulmonary fibrosis, and sever pulmonary emphysema
10. Sever infection
11. Active cancers
12. Past history of leukemia, lymphoma and myelodysplastic syndrome
13. Having treatment with major tranquilizer, antidepressant, and antimanic
14. Psychiatric diseases
Target sample size 37

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name Yamaguchi
Organization Mie University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5418
Email myamaguchi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Kazuyuki
Middle name
Last name Shimada
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code 466-8550
Address 65, Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2145
Homepage URL
Email kshimada@med.nagoya-u.ac.jp

Sponsor
Institute IVL study group in Japan
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mie University Hospital Clinical Review Board
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel 059-231-5045
Email s-kenkyu@mo.medic.mie-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs041180165
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長野赤十字病院（長野県）
大網白里市立国保大網病院（千葉県）
新潟大学医歯学総合病院（新潟県）
名古屋第二赤十字病院（愛知県）
名古屋市立大学病院（愛知県）
亀田総合病院（千葉県）
名古屋記念病院（愛知県）
東北大学病院（宮城県）
藤田医科大学病院（愛知県）
虎の門病院分院（神奈川県）
岡山大学病院（岡山県）
富山県立中央病院（富山県）
栃木県立がんセンター（栃木県）
久留米大学医学部附属病院（福岡県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部附属病院（愛知県）
三重大学医学部附属病院（三重県）
第二大阪警察病院（大阪府）
大分県立病院（大分県）
国立がん研究センター東病院（千葉県）
北海道大学病院（北海道）
一宮市立市民病院（愛知県）

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30059-0/fulltext
Number of participants that the trial has enrolled 38
Results 
With a median follow-up of 3.9 years (IQR 2.5 to 5.5), 2-year progression-free survival was 76% (95% CI 58 to 87). 2-year overall survival was 92% (95% CI 77 to 97). The cumulative incidence of secondary CNS recurrence at 2 years was 3% (95% CI 0.2 to 12).
Results date posted
2020 Year 06 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 03 Month 11 Day
Baseline Characteristics
Participant flow
Adverse events 
The most frequent adverse events of grade 3 to 4 were neutropenia and leucocytopenia, which were observed in all 38 (100%) patients. Serious adverse events were hypokalemia, febrile neutropenia with hypotension, hypertension, and intracerebral hemorrhage (reported in one [3%] patient each). No treatment-related deaths occurred during protocol treatment.
Outcome measures 
The primary endpoint was progression-free survival at 2 years. Secondary endpoints were overall survival at 2 years; the complete response rate according to our modified response criteria; cumulative incidence of secondary CNS involvement at 2 years; adverse events; and the pattern of progression.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2011 Year 05 Month 02 Day
Date of IRB
2011 Year 06 Month 16 Day
Anticipated trial start date
2011 Year 06 Month 16 Day
Last follow-up date
2021 Year 07 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 02 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006733