JPRN-jRCTs031180169进行中（未招募）3 期
JCOG1111C: A phase III study comparing interferon-alpha and zidovudine with watchful waiting for indolent adult T-cell leukemia-lymphoma - IFN/AZT vs WW for indolent ATL P-III
MINAMI Yosuke0 个研究点目标入组 38 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
研究者
相似试验
已完成
3 期
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)Adult T-cell leukemia-lymphomaJPRN-UMIN000011805Japan Clinical Oncology Group (JCOG)74
招募中
不适用
Sleep electroencephalogram (EEG) recordings in interferon-alpha treated hepatitis C patients – Pilot StudyMood side effects of interferon alpha treatmentMood effects of interferon treatment of hepatitis C patientsMental Health - DepressionACTRN12608000526370nited Hospitals Bristol15
招募中
不适用
Emotional Processing in Interferon-treated Hepatitis C patientsACTRN12608000525381nited Bristol Hospitals50
招募中
3 期
The effect of interferon on the treatment of covid19 patientsIRCT20160118026097N3Ghoum University of Medical Sciences60
撤回
不适用
A clinical study to investigate Interferon gamma (IFN*) signature in patients post HSCT and in patients with impaired HSC proliferation pre-transplantgraft failuregraft versus host disease and impaired hematopoietic stem cell proliferation100243241000533010003816NL-OMON52048Swedish Orphan International15