EUCTR2007-007756-34-ES进行中（未招募）1 期
ESTUDIO EN FASE II, ABIERTO, MULTICÉNTRICO, DE UN SOLO GRUPO, PARA DETERMINAR LA EFICACIA Y LA SEGURIDAD DE LA MONOTERAPIA CON LENALIDOMIDA (REVLIMID®) EN PACIENTES CON LNH DE CÉLULAS DEL MANTO QUE HAN RECIDIVADO O PROGRESADO TRAS EL TRATAMIENTO CON BORTEZOMIB O QUE SON RESISTENTES AL BORTEZOMIB. Estudio EMERGE - the Emerge trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 133
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Must understand and voluntarily sign an informed consent form.
- •Must be = 18 years of age at the time of signing the informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Biopsy-proven mantle cell NHL, including overexpression of cyclin D1 by immunohistochemistry or t(11;14)(q13;q32) by FISH. In patients whose tumors are negative for the cyclin D1 overexpression or translocation, overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable.
- •Must have received all of the following agents (alone or in combination). (There is no limit on the number of agents or prior therapies). The following agents can be given in any combination:
- •- Anthracycline or mitoxantrone
- •- Cyclophosphamide
- •- Rituximab
- •-Bortezomib
- •Patients must have documented relapsed, refractory or PD after treatment with bortezomib (or a bortezomib containing regimen) based on the following definitions:
- •- Relapsed lymphoma: patients with relapse within one year of last dose of bortezomib (or a bortezomib containing regimen) following initial response of CR to bortezomib (or a bortezomib containing regimen)
- •- Lymphoma refractory to bortezomib: patients with PD without any documented response of PR or better during treatment with bortezomib (or a bortezomib containing regimen) and having received at least 2 cycles of bortezomib (or a bortezomib containing regimen)
- •- Progressive disease: patients with PD within one year of last dose of bortezomib (or bortezomib containing regimen) following initial response of PR to bortezomib (or a bortezomib containing regimen)
- •Patients who have relapsed following high dose chemotherapy/autologous stem cell transplant are eligible.
- •Must have measurable disease on cross sectional imaging by CT that is at least 2 cm in the longest diameter and measurable in two perpendicular dimensions.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- •Life expectancy of = 90 days (3 months).
- •Females of child-bearing potential (FCBP) must agree to:
- •-Have two medically supervised pregnancy tests prior to starting of study therapy. The first pregnancy test will be performed within 10-14 days prior to the start of lenalidomide and the second pregnancy test will be performed within 24 hours prior to the start of lenalidomide. She must also agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
- •-Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
- •Male patients must:
- •-Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
- •-Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
- •All patients must:
- •-Have an understanding that the study drug could have a potential teratogenic risk.
- •- Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug thera
排除标准
- •Diagnosis of lymphoma other than MCL.
- •Transformed lymphoma
- •Any of the following laboratory abnormalities.
- •- Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L).
- •- Platelet count < 60,000/mm^3 (60 x 10^9/L).
- •- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 5.0 x upper limit of normal (ULN).
- •- Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin > 0.8mg/dL, except in case of hemolytic anemia.
- •Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min
- •Active central nervous system (CNS) lymphoma with the exception of those patients whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT are eligible. Patients with a history of CNS involvement or CNS symptoms will be required to have negative cerebrospinal fluid (CSF) cytology examination and a head CT during the screening period
- •Patients who have relapsed following allogeneic stem cell transplant and who have persistent donor hematopoiesis are not eligible.
- •Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible.
- •Patients should not be receiving corticosteroids except for prednisone = 10 mg/day or equivalent for purposes other than treating MCL.
- •Patients not willing to take deep vein thrombosis (DVT) prophylaxis.
- •Prior history of malignancies, other than MCL, unless the patient has been free of the disease for = 3 years. Exceptions include the following:
- •- Basal cell carcinoma of the skin
- •- Squamous cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of the breast
- •- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- •Uncontrolled intercurrent illness including, but not limited to:
- •- Ongoing or active infection requiring parenteral antibiotics
- •- Uncontrolled diabetes mellitus
- •- Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease)
- •- Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 180 days (6 months)
- •- Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with controlled atrial fibrillation that is asymptomatic are eligible.
- •Desquamating (blistering) rash while taking thalidomide
- •Patients with = Grade 2 neuropathy
- •Prior use of lenalidomide
- •Use of the following prior to initiation (day 1 cycle 1) of study drug:
- •- Prior chemotherapy within 2 weeks (with recovery of bone marrow function),
- •- Nitrosoureas within 6 weeks
- •- Antibody agents within 8 weeks
- •- Radioimmunoconjugate within 12 weeks
- •- Radiation therapy within 3 weeks (except for cranial RT and electron beam)
- •Any serious medical condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Pregnant or lactating females.
- •Any condition, including the presence of laboratory abnormalities, whi
研究者
相似试验
进行中（未招募）
1 期
ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y DE GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE DIFERENTES REGÍMENES DE DOSIS DE LENALIDOMIDA (REVLIMID®) EN SUJETOS CON LEUCEMIA LINFOCÍTICA CRÓNICA DE CÉLULAS B RESISTENTE O EN RECAÍDA.(A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY OF THE SAFETY AND EFFICACY OF DIFFERENT LENALIDOMIDE (REVLIMID®) DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA)Tratamiento de los pacientes con leucemia linfocítica crónica (LLC) de células B en los que han fracasado entre 1 y 3 tratamientos previos.(Relapsed Or Refractory B-Cell Chronic Lymphocytic Leukemia)MedDRA version: 9.1Level: LLTClassification code 10003946Term: B-Lymphocytic, CLL (Kiel Classification)EUCTR2009-009836-54-ESCelgene Corporation120
进行中（未招募）
不适用
ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD).EUCTR2010-023017-65-ESPFIZER, S.L.U.275
进行中（未招募）
不适用
ESTUDIO EN FASE II ABIERTO, ADAPTATIVO, MULTICÉNTRICO, CON AUMENTO Y AJUSTE DE LA DOSIS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE LA ADMINISTRACIÓN SUBCUTÁNEA REPETIDA DE DISTINTAS DOSIS DE BIM 23A760 EN PACIENTES CON SÍNDROME CARCINOIDE.Phase II, open, adaptive, dose escalating, multicentre titration study to assess the efficacy and safety of repeated subcutaneous administration of different doses of BIM 23A760 in patients with carcinoid syndromeEUCTR2009-013222-16-ESIpsen Pharma80
进行中（未招募）
不适用
Estudio en fase II, abierto, multicéntrico, prospectivo y aleatorizado, con DTIC o la combinación de Gemcitabina y DTIC en sarcomas de partes blandas avanzados del adultoEUCTR2005-001709-24-ESGrupo Español de Investigación en Sarcomas (GEIS)
进行中（未招募）
不适用
Estudio de Fase II multicéntrico, abierto con dos fases para la evaluación preliminar de la eficacia y la seguridad de E 7389 en pacientes con cáncer de próstata avanzado o metastásico refractario a tratamiento hormonal, se realizara una estratificación en relación a la quimioterapia previaA Phase II Multicenter, Open Label, Two-Stage Design Study EvaluatingE7389 in Patients with Hormone Refractory Prostate Cancer withAdvanced and/or Metastatic Disease Stratified by Prior Chemotherapy. - E7389-G000-204EUCTR2005-004271-37-ESEisai Limited110