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

NCT04992377 | Unknown Phase 2 FDA Drug

• 1 other identifier: IHBDH-IIT2021015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 11

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.

Conditions

Richter Transformation

Keywords

Richter transformation; chronic lymphocytic leukemia; R-EPOCH; Ibrutinib; Therapeutics

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival rate (OS)

  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.

  2 years

Secondary Outcomes (5)

• Complete response rate (CRR)

  1 month after completion of consolidation therapy

• Overall response rate (ORR)

  1 month after completion of consolidation therapy

• Progression-free survival (PFS)

  2 years

• Minimal residual disease (MRD) negative rate

  1 month after completion of consolidation therapy

• Toxic side effects

  3 years

Study Arms (1)

R-EPOCH plus IBR for RT

EXPERIMENTAL

Drug: R-EPOCH in Combination With Ibrutinib

Interventions

R-EPOCH in Combination With Ibrutinib DRUG

Induction: (21-day per cycle) Ibrutinib:420mg given orally , once daily. Details of R-DA-EPOCH are as follows: Rituximab: 375 mg/m2 given intravenously (IV) on day 0 Etoposide: 50 mg/m2 given CIV from day 1-4 Doxorubicin: 10 mg/m2 given CIV from day 1-4 Vincristine: 0.4 mg/m2 given CIV from day 1-4 Cyclophosphamide: 750 mg/m2/day IV on day 5 Prednisone: 60 mg/m2 given orally bid on days 1-5. Patients who achieve CR after 4 cycles enter the consolidation treatment ; Patients with PR after 4 cycles would receive another 2 cycles of R-EPOCH + ibrutinib induction therapy, they could enter the consolidation treatment if they achieve CR ,withdrawn from the study if they achieve ≤ PR; Patients with SD/PD after 4 cycles of treatment are withdrawn from the study. Consolidation: 2 cycles of R-EPOCH + Ibrutinib (dose as before) treatment Maintenance: Ibrutinib 420 mg/day for 24 months or until disease progression or intolerable toxicity

R-EPOCH plus IBR for RT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• ECOG 0-2
• Confirmed Richter transformation, whether or not previously treated
• Unexposed to BTKi, or discontinue BTKi more than 1 year (due not to toxicity or ineffectiveness)
• 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
• The patient agreed to participate and signed the informed consent form

You may not qualify if:

• Major surgery within 4 weeks prior to first dose of ibrutinib
• Require receiving anticoagulation with warfarin or equivalent Vitamin K antagonists; Requires treatment with a strong CYP3A4/5 inhibitor
• Require corticosteroid , anti-cancer drugs, immunomodulatory or Chinese medicine for other medical conditions
• Pregnant or lactating women
• History of prior malignancy
• Currently active clinically significant cardiovascular disease
• Uncontrolled active systemic fungal, bacterial, viral, or other infection
• Known history of human immunodeficiency virus (HIV) or active infection with Hepatitis B or Hepatitis C
• History of stroke or intracranial hemorrhage prior to randomization
• Other conditions that is unfit for the clinical trial in the investigator' opinion

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (11)

Peking university Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The second hospital of Hebei medical university

Shijiazhuang, Hebei, 050000, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The second Xiangya hospital of central south university

Changsha, Hunan, 410012, China

Location

The First affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First affiliated hospital of China medical university

Shenyang, Liaoning, 110122, China

Location

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, 250022, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

Tianjin university general hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tingyu Wang

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingyu Wang

CONTACT

+86 15692201678; wangtingyu@ihcams.ac.cn

Shuhua Yi

CONTACT

+86 15900265415; yishuhua@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 5, 2021
• Study Start: August 30, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: August 5, 2021

Record last verified: 2021-07

Locations

CN (11)