Adult T-cell leukemia-lymphoma
Conditions
Interventions
A: Watchful Waiting
B: Treatment with combination of IFN-alpha and AZT
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKenji Ishitsuka
JCOG1111 Coordinating Office Division of Hematology and Immunology, Kagoshima University Medical and Dental Hospital
Outcome results
None listed