JCOG1111C: A phase III study comparing IFN/AZT with WW for indolent ATL

JRCT ID: jRCTs031180169

Registered date:01/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia-lymphoma
• Date of first enrollment: 26/11/2013
• Target sample size: 38
• Study type: Interventional

Intervention(s)

[A] Watchful Waiting:
Observation without systemic treatment as an outpatient
[B] Treatment with combination of IFN-alpha and AZT:
day 1-7: IFN-alpha 3,000,000 U/body subcutaneous injection (sc.) once a day and AZT 600 mg/body/day internally 3 times a day,
day 8-84: IFN-alpha 6,000,000 U/body sc. once a day and AZT 600 mg/body/day internally 3 times a day,
day 85-: IFN-alpha 3,000,000 U/body sc. once a day and AZT 400 mg/body/day internally twice a day

Outcome(s)

• Primary Outcome: Event-free survival
• Secondary Outcome: Overall survival, acute transformation-free survival, other systemic treatment-free survival, additional treatment-free survival, overall response rate, and dose intensity. Proportion of adverse events, grade 4 non-hematological adverse events, early death, and treatment related death.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) Hematocytologically or pathologically proved peripheral lymphoid malignancy expressing T cell phenotype with positivity of anti-HTLV-1 antibody.
(2) Fulfilling either of [I.] or [II.]
[I.] Symptomatic smoldering ATL
Fulfilling all of (a) to (e)
(a) Lymphocytes < 4,000 /mm3
(b) LDH =< 333 U/L
(c) Corrected Ca < 11.0 mg/dL
(d) No ATL lesions in either of lymph node, liver, spleen, central nervous system, bone, ascites, pleural effusion, or gastrointestinal tract
(e) Fulfilling either of [1] or [2]
[1] The history of opportunistic infections within a year if there are no histologically proved ATL lesions in either of skin or lung and the proportion of abnormal lymphocytes in peripheral blood is >= 5%.
[2] Histologically proved ATL lesions in either of skin and/or lung.
[II.] Chronic ATL without unfavorable prognostic factors
Fulfilling all of (a) to (e)
(a) Lymphocytes >= 4,000 /mm3
(b) Corrected Ca < 11.0 mg/dL
(c) No ATL lesions in either of central nervous system, bone, ascites, pleural effusion, or gastrointestinal tract
(d) Fulfilling either of [1] or [2]
[1] No histologically proved ATL lesions, and the proportion of abnormal lymphocytes in peripheral blood >= 5%.
[2] Histologically proved ATL lesions in either of skin, lung, lymph node, liver, and/or spleen.
(e) Fulfilling all of [1] to [3]
[1] BUN =< 25 mg/dL
[2] LDN =< 300 U/L
[3] Albumin => 3.5 g/dL
(3) Aged 20 to 75 years old
(4) ECOG performance status of 0 or 1
(5) Fulfilling both of [I.] and [II.]
[I.] No prior treatment for ATL
[II.] 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

Exclude 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 difficult to participate in this clinical study.
(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, myocardiac 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

Related Information

• Primary Sponsor: MINAMI Yosuke
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000011805