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

Phase 3

• Conditions: Adult T-cell leukemia-lymphoma

• Registration Number: JPRN-jRCTs031180169
• Lead Sponsor: MINAMI Yosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

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 [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

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival

Secondary Outcome Measures

Name	Time	Method
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.