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
Overview
- Phase
- Phase 2
- Intervention
- Glofitamab
- Conditions
- Diffuse Large B-Cell Lymphoma-Recurrent
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- complete response rate (CR)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
This is an open-label, single-arm, single-center study to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in the patient ≥ 18 years of age with recurrent/refractory diffuse large B-cell lymphoma. Subjects who meet the eligibility criteria will receive combination therapy of Glofitamab, chidamide. The study will include the following sequential phases: screening, treatment, and follow-up.
Investigators
Huilai Zhang
Director of lymphoma department
Tianjin Medical University Cancer Institute and Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Any subject who meets any of the following criteria should not be enrolled in the study:
- •Inability to comply with protocol-specified hospitalization and restrictions
- •Richter's transformation
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations
- •Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)
- •Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen \[HBsAg\] serology).
- •Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody \[HBcAb\] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy.
- •Positive Hepatitis C virus (HCV) Antibody test
- •Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA.
- •Known HIV seropositive status
Arms & Interventions
combination therapy of Glofitamab, chidamide
Each subject will be given combination therapy of Glofitamab, chidamide. Glofitamab Injection with 2.5 mg on D8 and 10 mg on D15 in Cycle 1; with 30mg in Cycle 2-12, every 3 weeks.
Intervention: Glofitamab
combination therapy of Glofitamab, chidamide
Each subject will be given combination therapy of Glofitamab, chidamide. Glofitamab Injection with 2.5 mg on D8 and 10 mg on D15 in Cycle 1; with 30mg in Cycle 2-12, every 3 weeks.
Intervention: Chidamide
Outcomes
Primary Outcomes
complete response rate (CR)
Time Frame: up to the end of 12 cycles of treatment (each cycle is 28 days)
To assess the complete response rate (CR) at the end of treatment with Glofitamab combination with chidamide.
Secondary Outcomes
- Overall Response Rate (ORR)(up to the end of 12 cycles of treatment (each cycle is 28 days))
- Progression-free survival (PFS)(up to 2 years)
- Duration of Response (DoR)(up to 2 years)
- OS(up to 2 years)