ISRCTN52839057进行中（未招募）未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31109313 protocol (added 22/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for the Randomised Trial:
- •1. Suitable for anthracycline-containing chemo-immunotherapy
- •2. Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS
- •3. ECOG performance status of 0, 1, 2 or 3
- •4. Age 16 years and over
- •5. Signed written informed consent prior to performing any study-specific procedures
- •Inclusion criteria Cohort 1 (progressive RS following chemo-immunotherapy):
- •1. Patients with relapsed/refractory RS who received anthracycline based chemotherapy with anti-CD20 monoclonal antibody
- •2. ECOG performance status of 0, 1, 2 or 3
- •3. Age 16 years and over
- •4. Signed written informed consent prior to performing any study-specific procedures
- •Inclusion criteria Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib):
- •1. Ibrutinib-exposed CLL patients who have developed biopsy-proven DLBCL-type RS within four weeks of last dose of ibrutinib
- •2. No previous anthracycline treatment and suitable for anthracycline-containing chemo-immunotherapy
- •3. Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS
- •4. ECOG performance status of 0, 1, 2 or 3
- •5. Age 16 years and over
- •6. Signed written informed consent prior to performing any study-specific procedures
排除标准
- •Exclusion criteria ALL:
- •1. Known central nervous system (CNS) involvement of CLL or DLBCL
- •2. 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
- •3. Chronic or ongoing active infectious disease
- •4. Positive serology for Hepatitis B (HBKnown human immunodeficiency virus (HIV) positive
- •5. Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease)
- •6. Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenoprocoumon)
- •7. Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) > 2 x the upper limit of normal (ULN)
- •8. Major surgery within 30 days prior to randomisation and/or inadequate recovery from any prior major surgery, toxicity or complications
- •9. Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function
- •10. 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
- •11. Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- •12. History of significant cerebrovascular disease in the 6 months prior to randomisation, including intracranial haemorrhage
- •13. Known or suspected hypersensitivity to components of the investigational products
- •14. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment
- •15. Current participation in any other interventional clinical study
- •16. Patients known or suspected of not being able to comply with a study
- •17. Breastfeeding women or women with a positive pregnancy test at screening
- •18. Women of childbearing potential and men not willing to use adequate contraception during study and for 3 months after last dose of study therapy
- •Additional exclusion criteria for the Randomised Trial:
- •1. Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation
- •2. 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)
- •3. Previous acalabrutinib exposure
- •Additional exclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy):
- •1. Previous acalabrutinib exposure
- •Additional exclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib):
- •1. Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation
- •2. Previous acalabrutinib exposure
研究者
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