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Epigenetic-guided clinical trial of sidarbenamine combined with R-CHOP in the initial treatment of B-cell lymphoma

Epigenetic-guided clinical trial of sidarbenamine combined with R-CHOP in the initial treatment of B-cell lymphoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057712
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphoma

Interventions

Observation group:Chidamide Combined with R-CHOP Regimen

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Pathological biopsy diagnosis was consistent with B-cell lymphoma according to WHO 2016 classification criteria, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) grade I-III, marginal zone B-cell lymphoma (MALT), lymphoplasmacytic lymphoma (LPL), small lymphocytic B-cell lymphoma (SLL), mantle cell lymphoma (MCL), transforming lymphoma (TL), etc.; 3. Epigenetic gene mutations were detected by high throughput sequencing in pathological tissues or peripheral blood: EZH2, TET2, KMT2C(MLL3), KMT2D(MLL2), MEF2B, EP300, CREBBP, IDH2, PHF6, SF3B1, SPEN; 4. 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) >= 1.5cm, without considering the diameter of the short axis); 5. The physical status of the Eastern Cancer Collaboration Group (ECOG) was less than 2 points; 6. Adequate liver function: bilirubin =35mL/min as calculated by Cockcroft-Gault formula; 7. Voluntary participation, willingness to provide the above treatment data, signed and dated informed consent.

Exclusion criteria

Exclusion criteria: 1. Enrolled in other clinical trials; 2. Being treated with immunosuppressive therapy for other diseases; 3. Had received other treatments for lymphoma before enrollment; 4. Complicated with other malignant tumors; 5. The researcher decided that it is not suitable to participate in this study; 6. Severe mental or neurological conditions that affect informed consent and/or expression or observation of adverse reactions; 7. Patients could not be followed up; 8. Pregnant and lactating patients and patients of childbearing age who do not want to take contraceptive measures; 9. Active infection of HBV and HCV.

Design outcomes

Primary

MeasureTime frame
Complete remission rate ;

Secondary

MeasureTime frame
Progression free survival;Overall survival;Objective response rate;

Countries

China

Contacts

Public ContactJing Hongmei

Peking University Third Hospital

hongmeijing@bjmu.edu.cn+86 13661112910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026