UMIN-CTR Clinical Trial

Basic information
Public title	A phase III study comparing interferon-alpha and zidovudine with watchful waiting for indolent adult T-cell leukemia-lymphoma (JCOG1111C, IFN/AZT vs WW for indolent ATL P-III)
Acronym	IFN/AZT vs WW for indolent ATL P-III (JCOG1111C)
Scientific Title	A phase III study comparing interferon-alpha and zidovudine with watchful waiting for indolent adult T-cell leukemia-lymphoma (JCOG1111C, IFN/AZT vs WW for indolent ATL P-III)
Scientific Title:Acronym	IFN/AZT vs WW for indolent ATL P-III (JCOG1111C)
Region	Japan

Condition
Condition	Adult T-cell leukemia-lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm the superiority of the first line treatment with combination of interferon-alpha and zidobudine in overall survival compared with the current standard of care, watch and wait, for symptomatic smoldering type ATL and chronic type ATL without unfavorable prognostic factors.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Event-free survival
Key secondary outcomes	Overall survival, acute transformation-free survival, other systemic treatment-free survival, additional treatment-free survival, and overall response rate, and dose intensity. Proportopn of adverse events, grade 4 non-hematological adverse events, early death, and treatment related death.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Watchful Waiting
Interventions/Control_2	B: Treatment with combination of IFN-alpha and AZT
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Hematocytologically or pathologically proved peripheral lymphoid malignancy expressing T cell phenotype with positivity of anti-HTLV-1 antibody. 2) Fulfilling either of 1 or 2 1. Symptomatic smoldering ATL Fulfilling all of (1) to (5) (1) Lymphocytes < 4,000/mm3 (2) LDH =< 333 U/L (3) Corrected Ca < 11.0 mg/dL (4) No ATL lesions in either of lymph node, liver, spleen, central nervous system, bone, ascites, pleural effusion, or gastrointestinal tract (5) Fulfilling either of (i) or (ii) (i) The history of opportunistic infections within a year if there are no histologically proved ATL lesions in either of skin or lung and abnormal lymphocytes in peripheral blood were >= 5%. (ii) Histologically proved ATL lesions in either of skin and/or lung. 2. Chronic ATL without unfavorable prognostic factors Fulfilling all of (1) to (5) (1)Lymphocytes >= 4,000/mm3 (2)Corrected Ca < 11.0 mg/dL (3)No ATL lesions in either of central nervous system, bone, ascites, pleural effusion, or gastrointestinal tract (4)Fulfilling either of (i) or (ii) (i)No histologically proved ATL lesions, and abnormal lymphocytes in peripheral blood >= 5%. (ii)Histologically proved ATL lesions in either of skin, lung, lymph node, liver, and/or spleen. (5) Fulfilling all of (i) to (iii) (i)BUN =< 25 mg/dL (ii)LDN =< 300 U/L (iii)Albumin => 3.5 g/dL 3)Aged 20 to 75 years old 4)ECOG performance status of 0 or 1 5)Fulfilling both of 1 and 2 1. No prior treatment for ATL 2. No prior chemotherapy, interferon, AZT, and/or radiation therapy for any other malignancies. 6)Ejection fraction >= 50% by UCG 7)Adequate organ functions 8)Written informed consent
Key exclusion criteria	1) Synchronous or metachronous malignancy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) History of hypersensitivity to any of the components of the formulation in SumiferonTM 6) History of hypersensitivity to any of the components of the formulation in RetrovirTM 7) Prior allergic reactions to biological drugs including vaccines 8) Current treatment with Shosaiko-To 9) Current treatment with ibuprofen 10) Complication of autoimmune hepatitis 11) Psychiatric disease 12) Current treatment with systemic steroids 13) Poorly controlled diabetes mellitus or routine administration of insulin 14) Poorly controlled hypertension 15) Complication of unstable angina, cardiac infarction within 6 months, cardiomyopathy, cardiac failure, or arrhythmia requiring medical intervention 16) HBs-Ag positive 17) HCV-Ab positive 18) HIV-Ab positive 19) Complication of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema
Target sample size	74

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kunihiro Tsukasaki
Organization	Saitama Medical University International Medical Center
Division name	Department of Hematopoietic Tumor
Zip code
Address	1397-1, Ymane, Hidaka, Saitama, Japan
TEL	042-984-4111
Email	tsukasak@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kenji Ishitsuka
Organization	JCOG1111 Coordinating Office
Division name	Division of Hematology and Immunology, Kagoshima University Medical and Dental Hospital
Zip code
Address	8-35-1 Sakuragaoka, Kagoshima City,890-8544, Japan
TEL	099-275-5934
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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） 国立がん研究センター中央病院（東京都） NTT東日本関東病院（東京都） 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） 愛知医科大学病院（愛知県） 豊田厚生病院（愛知県） 三重大学医学部（三重県） 京都府立医科大学（京都府） 兵庫県立がんセンター（兵庫県） 広島大学病院（広島県） 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） 産業医科大学（福岡県） 佐賀大学医学部（佐賀県） 佐世保市総合医療センター（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） 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） 今村総合病院（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	2013 Year 09 Month 19 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	No longer recruiting
Date of protocol fixation	2012 Year 04 Month 11 Day
Date of IRB	2012 Year 06 Month 14 Day
Anticipated trial start date	2013 Year 09 Month 19 Day
Last follow-up date	2022 Year 09 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Advanced Medical Care B

Management information
Registered date	2013 Year 09 Month 19 Day
Last modified on	2019 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013709