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

• Status: Not yet recruiting
• Trial end date: 2025-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator-initiated Phase 2 study, which combines R-EDOCH with Ibrutinib to treat patients with Ritcher Transformation in consideration of DLBCL and CLL components both could being targeted at the same time. The investigator will observe the 2-year overall survival rate of this regimen for RT and explore the new regimen for RT in the novel drugs era, which aims to improve the efficacy and prolong survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborator: Xian-Janssen Pharmaceutical Ltd.

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