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

July 29, 2021 updated by: Tingyu Wang, Institute of Hematology & Blood Diseases Hospital

A Multicenter Phase 2 Study of R-EPOCH in Combination With Ibrutinib for Patients With Classical Richter Transformation of Chronic Lymphocytic Leukemia

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Jinhai Ren
      • Shijiazhuang, Hebei, China, 050011
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Keshu Keshu
    • Hunan
      • Changsha, Hunan, China, 410012
        • The Second Xiangya Hospital Of Central South University
        • Contact:
        • Principal Investigator:
          • Hongling Peng
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Fei Li
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110122
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • XiaoJing Yan
    • Shandong
      • Jinan, Shandong, China, 250022
        • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin University General Hospital
        • Contact:
          • Jia Song
          • Phone Number: +86 13512055651
        • Principal Investigator:
          • Jia Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-EPOCH plus IBR for RT
Drug: R-EPOCH in Combination With Ibrutinib

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival rate (OS)
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR)
Time Frame: 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.
1 month after completion of consolidation therapy
Overall response rate (ORR)
Time Frame: 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.
1 month after completion of consolidation therapy
Progression-free survival (PFS)
Time Frame: 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.
2 years
Minimal residual disease (MRD) negative rate
Time Frame: 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.
1 month after completion of consolidation therapy
Toxic side effects
Time Frame: 3 years
Non-hematologic toxicity was evaluated according to NCI CTCAE 5.0 criteria; hematologic toxicity was evaluated according to NCI CLL 2018 criteria
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital

Collaborators

Xian-Janssen Pharmaceutical Ltd.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2021

Primary Completion (Anticipated)

August 30, 2024

Study Completion (Anticipated)

August 30, 2025

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IHBDH-IIT2021015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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