NL-OMON38396撤回3 期
A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy. - Lenalidomide maintenance therapy in cutaneous T-cell lymphoma patients.
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •At registration
- •* Advanced stage mycosis fungoides (stage IIB-IV), or Sézary Syndrome.
- •* Prior debulking therapy with either gemcitabine or liposomal doxorubicin, resulting in complete or partial response as defined in this protocol's Evaluation criteria chapter. At the time of registration, patients provide consent for the collection of this pre/post debulking assessment information.
- •* For patients with Sezary syndrome, Sezary cell burden has to be decreased by at least 50 percent after debulking.;All patients must receive one of the two permitted debulking regimens:
- •* Gemcitabine administered on days 1, 8, and 15 of a 28-day cycle at a dose of 1000 to 1200 mg/m2 intravenously over 30 minutes for a total of four cycles.
- •* Liposomal Doxorubicin administered on days 1 and 15 of a 28-day cycle at a dose of 20 mg/m2
- •intravenously over one hour for a total of four cycles.
- •* Local low-dose/energy ionizing radiation therapy may be used as part of the debulking process to treat lesions that do not respond after three cycles of debulking chemotherapy.
- •* No other drug may be part of the debulking regimen. The use of low-dose steroids as premedication is allowed at the investigator*s discretion.
- •* Disease not appropriate for skin-directed therapy, per local institution standards.
- •* Disease not previously treated with intravenous chemotherapy (except for the permitted debulking agents, used for that purpose immediately prior to this protocol, as described above).
- •* In addition to antineoplastic cytotoxic agents, for purposes of this protocol, the definition of intravenous chemotherapy also includes:
- •* Denileukin diftitox
- •*Antibodies or antibody conjugates
- •* Age > 18 years.
- •* WHO performance status 0-2.
- •* Life expectance greater than 12 months
- •* Adequate organ function
- •* Cardiovascular status <= New York Heart Association (NYHA) category II (refer to Appendix D).
- •* Hepatic: Total Bilirubin <= 1.5 x UNL, alkaline phosphatase (ALP) <= 3 x UNL, alanine
- •aminotransferase (ALT, SGPT) <= 3 x UNL, aspartate aminotransferase (AST, SGOT) <= 3 x UNL
- •* Renal: Electrolytes including sodium, potassium, chloride, blood urea nitrogen (all creatinine < UNL, creatinine clearance >= 60 ml/min (measured or calculated according to the
- •method of Cockcroft and Gault, Appendix E), uric acid, phosphorus, calcium (all * Hematological: Hemoglobin >= 10 g/dl, absolute neutrophil count >= 1.5 x 109/L,
- •platelets >= 60 x 109 /L.
- •* Thyroid testing: free T4 and TSH anti-coagulation therapy (e.g. Vitamin K) to keep the International normalized ratio (INR) in the range of 2-3;* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.;* Female subjects of childbearing potential (defined as any female subject unless she meets at least one of the following criteria: Age >=50 years and naturally amenorrheic for >= 1 year {amenorrhea following cancer therapy does not rule out childbearing potential}, premature ovarian failure confirmed by a specialist gynacologist, previous bilateral salpingo-oophorectomy or hysterectomy, XY genotype, Turner syndrome or uterin
排除标准
- •* Central nervous system involvement.
- •* Uncontrolled infectious disease, autoimmune disease, immunodeficiency, or history of either
- •splenectomy or splenic irradiation.
- •* Second malignancies in the 3 years prior to study entry with the exception of surgically cured
- •carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate
- •cancer, and basal/squamous cell carcinoma of the skin.
- •* Pregnant or breast feeding subjects.
- •* Lapp lactase deficiency or history of glucose-galactose malabsorption.
- •*Radiation or drug-based therapy (including steroids) between registration and randomization.
研究者
相似试验
进行中（未招募）
1 期
A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 14.1Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 100000004864EUCTR2009-011020-65-DEEuropean Organisation for Research and Treatment of Cancer30
进行中（未招募）
1 期
A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 14.1 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndrome System Organ Class: 100000004864EUCTR2009-011020-65-GBEuropean Organisation for Research and Treatment of Cancer30
进行中（未招募）
不适用
A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 12.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeEUCTR2009-011020-65-NLEuropean Organisation for Research and Treatment of Cancer105
进行中（未招募）
1 期
A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 14.1Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 100000004864EUCTR2009-011020-65-BEEuropean Organisation for Research and Treatment of Cancer105
进行中（未招募）
1 期
A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy.Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 12.0 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndromeEUCTR2009-011020-65-FREuropean Organisation for Research and Treatment of Cancer30