R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jul 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Richter Transformation, a condition that can occur in people with chronic lymphocytic leukemia (CLL). The trial combines two treatments: R-EPOCH, a chemotherapy regimen, and Ibrutinib, a targeted therapy. The goal is to see if this combination can improve survival rates and effectively target both components of the disease at the same time.

To participate in the trial, individuals must be between the ages of 18 and 65, have a confirmed diagnosis of Richter transformation, and meet certain health criteria, including having no serious liver, kidney, or heart problems. Participants will be closely monitored over two years to assess how well the treatment works. It's important to note that the trial is not yet recruiting participants, so if you or someone you know is interested, keep an eye out for updates on when it will begin.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-65 years
• • 2. ECOG 0-2
• • 3. Confirmed Richter transformation, whether or not previously treated
• • 4. Unexposed to BTKi, or discontinue BTKi more than 1 year (due not to toxicity or ineffectiveness)
• • 5. No serious liver, kidney, heart and other complications; including: a. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); b. total bilirubin (TBIL) ≤ 1.5 times the ULN; c. serum creatinine (Cr) ≤ 2 times the ULN, or glomerular filtration rate ≥ 40ml/min; d. LVEF \> 50% determined by echocardiography; e. no arrhythmia and active heart disease, such as coronary heart disease, myocardial infarction, etc
• • 6. The patient agreed to participate and signed the informed consent form
• Exclusion Criteria:
• • 1. Major surgery within 4 weeks prior to first dose of ibrutinib
• • 2. Require receiving anticoagulation with warfarin or equivalent Vitamin K antagonists; Requires treatment with a strong CYP3A4/5 inhibitor
• • 3. Require corticosteroid , anti-cancer drugs, immunomodulatory or Chinese medicine for other medical conditions
• • 4. Pregnant or lactating women
• • 5. History of prior malignancy
• • 6. Currently active clinically significant cardiovascular disease
• • 7. Uncontrolled active systemic fungal, bacterial, viral, or other infection
• • 8. Known history of human immunodeficiency virus (HIV) or active infection with Hepatitis B or Hepatitis C
• • 9. History of stroke or intracranial hemorrhage prior to randomization
• • 10. Other conditions that is unfit for the clinical trial in the investigator' opinion