R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL (BDHRT001)

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Not yet enrolling; Phase 2

Conditions: Richter Transformation

Treatments: Drug: R-EPOCH in Combination With Ibrutinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04992377

IHBDH-IIT2021015

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

R-EPOCH plus IBR for RT

Experimental group

Treatment:

Drug: R-EPOCH in Combination With Ibrutinib