Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL (NCT06570447) | Clinical Trial Compass
RecruitingPhase 2
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
China22 participantsStarted 2025-02-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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)
. 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 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
complete response rate (CR)
Timeframe: up to the end of 12 cycles of treatment (each cycle is 28 days)
Trial details
NCT IDNCT06570447
SponsorTianjin Medical University Cancer Institute and Hospital
. 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).
. Positive Hepatitis C virus (HCV) Antibody test
. Known HIV seropositive status
. Known or suspected chronic active Epstein-Barr Viral infection