Richter TransformationPhase 2BDHRT001NCT04992377
R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL
A Phase 2 study testing R-EPOCH in Combination With Ibrutinib in people with Richter Transformation, run by Institute of Hematology & Blood Diseases Hospital, China at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Richter Transformation
- What is being tested?
- R-EPOCH in Combination With Ibrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesChina
- Study dates
- 30 Aug 2021to 30 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking university Third Hospital
Beijing, Beijing Municipality, 100191
Hongmei Jing, Hongmei_jing@163.com
Hongmei Jing
The First Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, oubai16@163.com
Ou Bai
The second Xiangya hospital of central south university
Changsha, Hunan, 410012
Hongling Peng, +86 13975806137, 577769365@qq.com
Hongling Peng
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, 250022
Zengjun Li, +86 13642138692, zengjunli@163.com
Zengjun Li
The First affiliated hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, +86 13767186425, yx021021@sina.com
Fei Li
The First affiliated hospital of China medical university
Shenyang, Liaoning, 110122
Xiaojing Yan, yanxiaojing_pp@hotmail.com
Xiaojing Yan
The second hospital of Hebei medical university
Shijiazhuang, Hebei, 050000
Jinhai Ren, Jinhai1966@sina.com
Jinhai Ren
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Lihong Liu, 13831177920@163.com
Lihong Liu
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Liping Su, sulp2015@163.com
Liping Su
Tianjin university general hospital
Tianjin, Tianjin Municipality, 300052
Jia Song, +86 13512055651
Jia Song
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Keshu Zhou, drzhouks77@163.com
Keshu Keshu
About this study
Official title: 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.
- Conditions
- Richter Transformation
- Being tested
- R-EPOCH in Combination With Ibrutinib
- Keywords
- Richter transformation, chronic lymphocytic leukemia, R-EPOCH, Ibrutinib, Therapeutics
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-EPOCH in Combination With IbrutinibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| R-EPOCH plus IBR for RT | Experimental | Not described Receives: Drug: R-EPOCH in Combination With Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Complete response rate (CRR)
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.
Measured: 1 month after completion of consolidation therapy
Overall response rate (ORR)
Defined as the percentage of subjects who achieved CR + PR after treatment in the per-protocol population and the intention-to-treat population.
Measured: 1 month after completion of consolidation therapy
Progression-free survival (PFS)
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.
Measured: 2 years
Minimal residual disease (MRD) negative rate
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.
Measured: 1 month after completion of consolidation therapy
Toxic side effects
Non-hematologic toxicity was evaluated according to NCI CTCAE 5.0 criteria; hematologic toxicity was evaluated according to NCI CLL 2018 criteria
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start30 Aug 2021 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Richter TransformationStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Responsible party
- Principal investigator, Tingyu Wang, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992377
- Sponsor's protocol ID
- IHBDH-IIT2021015
- Acronym
- BDHRT001
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Study of R-EPOCH in Combination With Ibrutinib for Patients With Classical Richter Transformation of Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT04992377
- Acronym / sponsor ID
- BDHRT001 / IHBDH-IIT2021015
- Conditions
- Richter Transformation
- Keywords
- Richter transformation, chronic lymphocytic leukemia, R-EPOCH, Ibrutinib, Therapeutics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-EPOCH plus IBR for RT | Experimental | Drug: R-EPOCH in Combination With Ibrutinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-EPOCH in Combination With IbrutinibInduction: (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 | Drug | R-EPOCH plus IBR for RT |
Primary outcome
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.
5 secondary outcomes
Complete response rate (CRR)
Time frame: 1 month after completion of consolidation therapy
Overall response rate (ORR)
Time frame: 1 month after completion of consolidation therapy
Progression-free survival (PFS)
Time frame: 2 years
Minimal residual disease (MRD) negative rate
Time frame: 1 month after completion of consolidation therapy
Toxic side effects
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-EPOCH in Combination With Ibrutinib in people with Richter Transformation, run by Institute of Hematology & Blood Diseases Hospital, China at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingyu Wang (+86 15692201678, wangtingyu@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival rate (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.