Clinical trial NCT04992377: R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL
Official title: A Multicenter Phase 2 Study of R-EPOCH in Combination With Ibrutinib for Patients With Classical Richter Transformation of Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Richter Transformation
Keywords: Richter transformation
chronic lymphocytic leukemia
R-EPOCH
Ibrutinib
Therapeutics
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Xian-Janssen Pharmaceutical Ltd.
First posted: 2021-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 2-year overall survival rate (OS)
timeFrame: 2 years
Secondary outcomes:
measure: Complete response rate (CRR)
timeFrame: 1 month after completion of consolidation therapy
measure: Overall response rate (ORR)
timeFrame: 1 month after completion of consolidation therapy
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Minimal residual disease (MRD) negative rate
timeFrame: 1 month after completion of consolidation therapy
measure: Toxic side effects
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university Third Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The second hospital of Hebei medical university
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The second Xiangya hospital of central south university
state: Hunan
city: Nanchang
country: China
facility: The First affiliated hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First affiliated hospital of China medical university
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin university general hospital
state: Tianjin
Study officials:
affiliation: State Key Laboratory of Experimental Hematology, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Tingyu Wang
role: PRINCIPAL_INVESTIGATOR
References: