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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019868
Receipt No. R000022939
Scientific Title Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Date of disclosure of the study information 2015/11/20
Last modified on 2015/11/20

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Basic information
Public title Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Acronym Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Scientific Title Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Scientific Title:Acronym Non-randomized confirmatory study of interim PET-guided ABVD or ABVD/escalated BEACOPP regimen for previously untreated advanced stage Hodgkin lymphoma (JCOG1305, INNOVATE-HL study)
Region
Japan

Condition
Condition Previously untreated advanced stage Hodgkin lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The objective of this trial is to confirm the utility of interim PET (after 2 cycles of ABVD as induction phase)-guided treatment strategy (followed by additional 4 cycles of ABVD if interim PET-negative or 6 cycles of escalated BEACOPP if interim PET-positive) for previously untreated advanced stage Hodgkin lymphoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 2-year progressin-free survival among all eligible patients and among inteim PET-positive patients (Co-primary endpoints)
Key secondary outcomes overall survival, event-free survival, complete response rate, incidence of adverse events, incidence of severe adverse events, incidence of secondary malignancy, incidence of per-protocol in terms of interim PET

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 After 2 cycles of ABVD for all patients, interim PET is performed.

Interim PET-negative patients receive additional 4 cycles of ABVD (every 4 weeks); doxorubicin 25mg/m2, div, day1and 15; bleomycin 9mg/m2 (max 15mg/body), div, day1 and 15; vinblastine 6mg/m2 (max 10mg/body), iv, day1 and 15; dacarbazine 375mg/m2, div, day1 and 15.

Interim PET-positive patients receive 6 cycles of escalated BEACOPP (every 3 weeks); bleomycin 10mg/m2 (max 15mg/body) div day8; etoposide 200mg/m2 div day1-3; doxorubicin 35mg/m2 div day1; cyclophosphamide 1250mg/m2 div day1; vincristine 1.4mg/m2 (max 2mg/body) iv day8; procarbazine 100mg/m2 po day1-7; prednisolone 40mg/m2 po day1-14; G-CSF sc day4-.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically diagnosed as classical Hodgkin lymphoma according to WHO classification 2008.
2) Clinical stage III or IV, or clinical stage IIB with bulky mediastinal lesion or continuously invasive lesion to extranodal tissues.
3) No central nervous system involvement
4) Aged 20 to 60 years old at enrollment
5) ECOG Performance status: 0-2
6) Having measuralble lesion (fulfill the 3 following criteria)
(1) lymph node or extranodal disease diagnosed as Hodgkin lymphoma by imaging, histopathological or cytopathological method.
(2) measurable lesion by CT scan (transverse imaging with bidimensional measurements)
(3) longest transverse diameter for lesions of 1.5 cm or more.
7) No previous anti-cancer treatment (chemotherapy and/or radiation) except for hormone therapy
8) Meet all of the following:
(1) absolute neutrophil count: no less than 1,000/mm3
(2) platelet count: no less than 100,000/mm3
(3) total bilirubin: 2.0 mg/dL or below
(4) AST(GOT) : no more than 150 U/L
(5) ALT(GPT) : no more than 150 U/L
(6) serum creatinine: 1.6 mg/dL or below (male), 1.2 mg/dL or below (female)
(7) fasting blood glucose: 150 mg/dL or below
(8) PaO2 (room air): at least 70 torr
9) ECG: neither ischemic change nor arrhythmia requiring medical intervention
10) Cardiac ejection fraction: at least 50%
11) Written informed consent by the patient
Key exclusion criteria 1) Synchronous or metachronous malignancy
2) Active infection requiring systemic treatment
3) Pregnant or nursing women
4) Psychiatric disease
5) Continuous systemic treatment with steroids or other immunosuppressive drugs
6) Insulin-dependent or uncontrollable diabetes mellitus
7) Unstable angina pectoris, or history of myocardial infarction within six months
8) Seropositive for HBsAg or anti-HCV antibody
9) Seropositive for anti-HIV antibody or unexamined
10) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema on chest CT
Target sample size 105

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Nagai
Organization National Hospital Organization Nagoya Medical Center
Division name Division of Hematology
Zip code
Address 4-1-1, Sannomaru, Naka-ku, Nagoya, 460-0001 Japan
TEL 052-951-1111
Email nagaih@nnh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Kusumoto
Organization JCOG1305 Coordinating Office
Division name Division of Hematology and Oncology, Nagoya City University Hospital
Zip code
Address 1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601 Japan
TEL 052-853-8738
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 国立病院機構北海道がんセンター(北海道)
札幌北楡病院(北海道)
東北大学病院(宮城県)
秋田大学医学部(秋田県)
群馬大学医学部附属病院(群馬県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
杏林大学医学部(東京都)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学第三病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
NTT東日本関東病院(東京都)
東海大学医学部(神奈川県)
金沢医科大学(石川県)
福井大学医学部附属病院(福井県)
浜松医科大学(静岡県)
愛知県がんセンター中央病院(愛知県)
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(愛知県)
名古屋市立大学病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知医科大学附属病院(愛知県)
豊田厚生病院(愛知県)
三重大学医学部(三重県)
滋賀県立成人病センター(滋賀県)
京都府立医科大学(京都府)
兵庫県立がんセンター(兵庫県)
岡山医療センター(岡山県)
広島大学病院(広島県)
国立病院機構四国がんセンター(愛媛県)
愛媛大学医学部附属病院(愛媛県)
国立病院機構九州がんセンター(福岡県)
福岡大学医学部(福岡県)
国立病院機構九州医療センター(福岡県)
佐賀大学医学部(佐賀県)
国立病院機構長崎医療センター(長崎県)
佐世保市立総合病院(長崎県)
長崎大学病院(長崎県)
日本赤十字社長崎原爆病院(長崎県)
熊本大学医学部(熊本県)
国立病院機構熊本医療センター(熊本県)
大分県立病院(大分県)
鹿児島大学医学部・歯学部附属病院(鹿児島県)
今村病院分院(鹿児島県)
琉球大学医学部附属病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 20 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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 20 Day
Last follow-up date
2024 Year 11 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 20 Day
Last modified on
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022939

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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