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

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Brief Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

2-year overall survival rate (OS)

Secondary Outcome

 Complete response rate (CRR)

Condition

Richter Transformation

Intervention

R-EPOCH in Combination With Ibrutinib

Study Arms / Comparison Groups

 R-EPOCH plus IBR for RT
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

August 30, 2021

Completion Date

August 30, 2025

Primary Completion Date

August 30, 2024

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Tingyu Wang, +86 15692201678, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04992377

Organization ID

IHBDH-IIT2021015


Responsible Party

Principal Investigator

Study Sponsor

Institute of Hematology & Blood Diseases Hospital

Collaborators

 Xian-Janssen Pharmaceutical Ltd.

Study Sponsor

Tingyu Wang, Principal Investigator, 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


Verification Date

July 2021