EUCTR2017-004401-40-GB进行中（未招募）1 期
STELLAR: A phase II, randomiSed study of CHOP-R in combination with acalabruTinib comparEd to CHOP-R in patients with newLy diagnosed Richter’s Syndrome (RS) and a pLAtfoRm for initial investigations into activity of novel treatments in relapsed/refractory and newly diagnosed RS. - STELLAR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
入选标准
- •Inclusion criteria for the Randomised Trial
- •-Suitable for anthracycline-containing chemo-immunotherapy.
- •-Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.
- •-ECOG performance status of 0, 1, 2 or 3.
- •-Age 16 years and over.
- •-Signed written informed consent prior to performing any study-specific procedures
- •Inclusion criteria Cohort 1 (progressive RS following chemo-immunotherapy)
- •-Patients with relapsed/refractory RS who received anthracycline based chemotherapy with anti-CD20 monoclonal antibody.
- •-ECOG performance status of 0, 1, 2 or 3.
- •-Age 16 years and over.
- •-Signed written informed consent prior to performing any study-specific procedures
- •Inclusion criteria Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib)
- •-Ibrutinib-exposed CLL patients who have developed biopsy-proven DLBCL-type RS within four weeks of last dose of ibrutinib.
- •-No previous anthracycline treatment and suitable for anthracycline-containing chemo-immunotherapy.
- •-Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.
- •-ECOG performance status of 0, 1, 2 or 3.
- •-Age 16 years and over.
- •-Signed written informed consent prior to performing any study-specific procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Exclusion criteria ALL
- •-Known central nervous system (CNS) involvement of CLL or DLBCL.
- •-Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin.
- •-Chronic or ongoing active infectious disease
- •-Positive serology for Hepatitis B (HBKnown human immunodeficiency virus (HIV) positive.
- •-Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease).
- •-Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenoprocoumon).
- •-Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) > 2 x the upper limit of normal (ULN).
- •-Major surgery within 30 days prior to randomisation and/or inadequate recovery from any prior major surgery, toxicity or complications.
- •-Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function.
- •-Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
- •-Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- •-History of significant cerebrovascular disease in the 6 months prior to randomisation, including intracranial haemorrhage.
- •-Known or suspected hypersensitivity to components of the investigational products
- •-Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment
- •-Current participation in any other interventional clinical study.
- •-Patients known or suspected of not being able to comply with a study
- •-Breast feeding women or women with a positive pregnancy test at screening.
- •-Women of childbearing potential and men not willing to use highly effective contraception during study and for 12 months after last dose of study therapy
- •Additional exclusion criteria for the Randomised Trial
- •-Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation.
- •-Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks of their last dose of ibrutinib. (Ibrutinib-exposed CLL patients who discontinue ibrutinib due to toxicity or progressive CLL and later (more than four weeks) develop RS are not excluded from the randomised trial component).
- •-Previous acalabrutinib exposure.
- •Additional exclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy)
- •-Previous acalabrutinib exposure.
- •Additional exclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib)
- •-Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation.
- •-Previous acalabrutinib exposure.
研究者
相似试验
进行中（未招募）
不适用
An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin versus R-CHOP in the First-Line Treatment of Patients with Intermediate and High-Risk Diffuse Large B-Cell Lymphoma - N/AFirst-Line Diffuse Large B-Cell LymphomaMedDRA version: 9.1Level: LLTClassification code 10012855Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation)EUCTR2008-005496-10-IEEli Lilly and Company100
进行中（未招募）
不适用
A trial of CHOP-R therapy, with or without acalabrutinib, in patients with newly diagnosed Richter's SyndromeRichter syndromeCancerISRCTN52839057niversity of Birmingham84
进行中（未招募）
1 期
Randomized phase II study of treatment with R-CHOP vs Bortezomib-R-CAP for young patients with poor IPI diffuse large B-cell lymphoma.EUCTR2012-005138-12-ESGELTAMO (Grupo Cooperativo Español de Linfoma/Trasplante Autólogo de Médula Ósea)127
已完成
2 期
Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)CD20 positive diffuse large B cell lmyphomaJPRN-UMIN000000929Japan Clinical Oncology Group(JCOG)422
已完成
2 期
Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )diffuse large B-cell lymphoma, including subtypeslymphomatoid granulomatosis, grade 3primary mediastinal (thymic) large B-cell lymphomaJPRN-UMIN000003823Japan Clinical Oncology Group (JCOG)70