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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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2 cycles of R-EPOCH + ibrutinib induction therapy, they could enter the consolidation treatment if they achieve CR ,withdrawn from the study if they achieve ≤ PR; Patients with SD/PD after 4 cycles of treatment are withdrawn from the study.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
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
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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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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
...and 1 more locations
Time frame: 3 years