R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL
NCT ID: NCT04992377
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2021-08-30
2025-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allogeneic Stem Cell Transplantation
NCT03153514
A Prospective Multicenter Phase 2 Study of FCR/BR Alternating With Ibrutinib in Treatment-naive Patients With CLL
NCT03980002
Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL
NCT04494503
Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation
NCT05672173
A Study to Evaluate ICP-022 in Patients With CLL/ SLL
NCT03493217
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
R-EPOCH plus IBR for RT
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xian-Janssen Pharmaceutical Ltd.
INDUSTRY
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tingyu Wang
associate chief physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tingyu Wang
Role: 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
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking university Third Hospital
Beijing, Beijing Municipality, China
The second hospital of Hebei medical university
Shijiazhuang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The second Xiangya hospital of central south university
Changsha, Hunan, China
The First affiliated hospital of Nanchang University
Nanchang, Jiangxi, 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 Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jia Song
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IHBDH-IIT2021015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.