Status:
UNKNOWN
Ibrutinib Combined With R-CHOP/R-DHAP in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged ≤65 Years
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
The Second Affiliated Hospital of Dalian Medical University
Peking University First Hospital
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of the study is to better and systematically collect clinical data on the treatment of ibrutinib combined with R-CHOP/DHAP regimen for more scientific and accurate evaluation, our center h...
Detailed Description
Mantle cell lymphoma (MCL) is a B-cell lymphoma with unique histomorphology、immunophenotype and cytogenetic characteristics, accounting for 6% to 8% of non-hodgkin's lymphoma, occurs in older men, med...
Eligibility Criteria
Inclusion
- age 18-65 years old;
- The pathological biopsy was consistent with mantle cell lymphoma;
- 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);
- The physical status of the Eastern United States Cooperative Oncology Group (ECOG) ≤2 points;
- 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;
- Voluntary participation, willingness to provide the above treatment data, signed and dated informed consent -
Exclusion
- Other clinical trials have been included;
- Immunosuppressive therapy is being used for other diseases;
- Lymphoma has been treated with other regimens before entry;
- Complicated with other malignant tumors;
- Those who are judged by the investigator to be unsuitable to participate in this study;
- Serious mental or neurological disorder that affects informed consent and/or the presentation or observation of adverse reactions;
- Patients who could not be followed up
- Exit (drop-off) criteria :
- Subject requires to quit;
- Serious adverse events occurred during the trial, so it is inappropriate to continue the clinical trial;
- If the disease progresses during the study, it is inappropriate to continue using the experimental drug and/or cannot continue the study protocol;
- Incomplete research data records;
- 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.
Key Trial Info
Start Date :
December 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05429918
Start Date
December 30 2020
End Date
June 30 2024
Last Update
June 23 2022
Active Locations (1)
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1
Hongmei Third Jing
Beijing, Beijing Municipality, China, 100083