An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma
An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.
• \- To be eligible for enrollment in this study, a subject must meet all of the following criteria:
• Signed informed consent
• Age ≥ 18 years at the time of informed consent
• Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures.
• Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL)
• \- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed).
• Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy).
‣ Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy.
⁃ CAR T cells plus bridging were counted as a treatment line.
⁃ Local therapies (e.g., radiotherapy) will not be considered as treatment lines.
• Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as \> 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as \> 1.0 cm in the longest diameter.
• Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are acceptable.
• Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1
• Life expectancy (as assessed by the investigator) ≥ 12 weeks
⁃ Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).
⁃ Adequate liver function
∙ Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin;
‣ AST/ALT ≤ 3 × ULN
⁃ Adequate hematological function:
∙ Neutrophil count ≥ 1.5 x 109 cells/L (1.500/μL);
‣ Platelet count ≥ 75,000/μL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1);
‣ Haemoglobin ≥ 10.0 g/dL (6.2 mmol/L); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1
⁃ Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL/min calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected by Serum creatinine levels as judged by the investigator)
⁃ Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of non-therapeutic Surgery) or Pregnancy test sterilized (absence of ovaries and/or uterus). For women of childbearing potential: Agree to remain abstinent (avoid heterosexual intercourse) or to take Contraception measures.
⁃ For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception