UMIN-CTR Clinical Trial

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

Adult T-cell leukemia-lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

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

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）

Date of disclosure of the study information

2013

Year

09

Month

19

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

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 related information

Advanced Medical Care B

Registered date

2013

Year

09

Month

19

Day

Last modified on

2019

Year

04

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013709