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

Phase 2

Not yet recruiting

• Conditions: Richter Transformation
• Interventions: Drug: R-EPOCH in Combination With Ibrutinib

• Registration Number: NCT04992377
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-29
• Last Update Submitted: 2021-07-29
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Study Start: 2021-08-30
• Primary Completion: 2024-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R-EPOCH plus IBR for RT	R-EPOCH in Combination With Ibrutinib	-

Primary Outcome Measures

Name	Time	Method
2-year overall survival rate (OS)	2 years	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 Outcome Measures

Name	Time	Method
Complete response rate (CRR)	1 month after completion of consolidation therapy	Defined as the percentage of subjects who achieved CR after treatment in the per-protocol population as well as in the intent-to-treat population.
Overall response rate (ORR)	1 month after completion of consolidation therapy	Defined as the percentage of subjects who achieved CR + PR after treatment in the per-protocol population and the intention-to-treat population.
Progression-free survival (PFS)	2 years	Defined as the time interval from enrollment to disease progression or death, whichever occurred first, for patients in the intent-to-treat (ITT) population. If there is no progression or time of disease progression is not recorded at the time of withdrawal from the trial, the date of the last examination will be used as the endpoint date.
Minimal residual disease (MRD) negative rate	1 month after completion of consolidation therapy	For patients with bone marrow invasion, on the basis of CR, multicolor flow cytometry detects that tumor cells account for the proportion of nuclear cells, and \< 0.01% are MRD negative.
Toxic side effects	3 years	Non-hematologic toxicity was evaluated according to NCI CTCAE 5.0 criteria; hematologic toxicity was evaluated according to NCI CLL 2018 criteria

Trial Locations

Locations (11)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

The First affiliated hospital of China medical university; 🇨🇳 Shenyang, Liaoning, China

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences; 🇨🇳 Jinan, Shandong, China

Shanxi Cancer Hospital; 🇨🇳 Taiyuan, Shanxi, China

Tianjin university general hospital; 🇨🇳 Tianjin, Tianjin, China

The second hospital of Hebei medical university; 🇨🇳 Shijiazhuang, Hebei, China

Peking university Third Hospital; 🇨🇳 Beijing, Beijing, China

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The second Xiangya hospital of central south university; 🇨🇳 Changsha, Hunan, China

The First affiliated hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China