Clinical trial · Observational
Ibrutinib Combined With Bendamustine and Rituximab in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged > 65 Years
A Multicenter Prospective Observational Study to Evaluate the Safety and Efficacy of Ibrutinib Combined With Bendamustine and Rituximab in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged > 65 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective observational clinical trial. A total of 19 research centers were involved in this study. Each site plans to enroll 2-3 patients, and a total of 60 patients will be enrolled. Patients who met the diagnosis of mantle cell lymphoma by histological examination, ECOG (Eastern Oncology Collaborative Group) score 0-2, age \>65 years, expected survival of more than 3 months, and at least one measurable lesion were included in this observational clinical trial. In this study, clinical data of patients treated with R-B regimen combined with ibrutinib will be collected, including routine clinical laboratory tests, examinations, and molecular biological data, for efficacy assessment and survival analysis. The main evaluation indicators are the total effective rate of 2 and 6 cycles of alternating R-CHOP/R-DHAP combined with ibrutinib in the treatment of newly treated muff cell lymphoma patients. The 3-year progression-free survival (PFS) and overall survival (OS) of the patients will be assessed, and adverse events to treatment will be collected to evaluate the safety of ibrutinib in combination with untreated mask cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- the overall response (complete response + partial response)
- timeFrame
- From the date of first study drug administration until the end of Cycle 2 (each cycle is 28 days)
- description
- Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL
- measure
- the overall response (complete response + partial response)
- timeFrame
- From the date of first study drug administration until the end of Cycle 6 (each cycle is 28 days)
- description
- Objective response rate，sum of complete response rate and partial response rate of ibrutinib combination therapy in initial treatment of MCL
Secondary outcomes (4)
- measure
- Progression-free survival (PFS),OS,CR,DOR
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 65 years old; 2. The pathological biopsy was consistent with mantle cell lymphoma; 3. Measurable lesions on cross-sectional imaging recorded by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) (defined as the presence of at least one two-dimensional measurable lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, regardless of the short axis diameter); 4. The physical status of the Eastern United States Cooperative Oncology Group (ECOG) ≤2 points; 5. Full liver function: upper limit of bilirubin≤3×normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Alkaline phosphatase (ALP) ≤5×ULN; Serum creatinine ≤1.5×ULN, or creatinine clearance rate calculated according to Cockcroft-Gault formula ≥35mL/min; 6. Voluntary participation, willingness to provide the above treatment data, signed and dated informed consent. Exclusion Criteria: 1. Other clinical trials have been included; 2. Immunosuppressive therapy is being used for other diseases; 3. Lymphoma has been treated with other regimens before entry; 4. Complicated with other malignant tumors; 5. Those who are judged by the investigator to be unsuitable to participate in this study; 6. Serious mental or neurological disorder that affects informed consent and/or the presentation or observation of adverse reactions; 7. Patients who could not be followed up; Exit (drop-off) criteria : 1. Subject requires to quit; 2. Serious adverse events occurred during the trial, so it is inappropriate to continue the clinical trial; 3. If the disease progresses during the study, it is inappropriate to continue using the experimental drug and/or cannot continue the study protocol; 4. Incomplete research data records; 5. Patients could not be followed up.Withdrawal cases should be retained for future reference and transferred from the last record to the final record for ITT analysis.
References
Publications (0)
Data not yet available