Clinical trial · Interventional
R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL
A Multicenter Phase 2 Study of R-EPOCH in Combination With Ibrutinib for Patients With Classical Richter Transformation of Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Richter Transformation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-EPOCH in Combination With Ibrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-EPOCH plus IBR for RT
- interventionNames
- Drug: R-EPOCH in Combination With Ibrutinib
Primary outcomes (1)
- measure
- 2-year overall survival rate (OS)
- timeFrame
- 2 years
- description
- Defined as the time interval from enrollment to death of patients in the intent-to-treat population (ITT). If the patient is alive or death of the patient is unknown, the date of death will be the latest time point at which the patient was known to be alive.
Secondary outcomes (5)
- measure
- Complete response rate (CRR)
- timeFrame
- 1 month after completion of consolidation therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available