Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Glofitamab
DrugFor Glofitamab Injection solution, after Obinutuzumab pretreatment on Day 1 of Cycle 1, patients followed a step-dose escalation regimen.
Chidamide
DrugChidamide: 20 mg/d orally twice a week for 21 days as a treatment cycle.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: combination therapy of Glofitamab, chidamideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
complete response rate (CR)
To assess the complete response rate (CR) at the end of treatment with Glofitamab combination with chidamide.
Time frame
up to the end of 12 cycles of treatment (each cycle is 28 days)Secondary outcomes
1
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment of Glofitamab combination with chidamide.
Time frame
up to the end of 12 cycles of treatment (each cycle is 28 days)2
Duration of Response (DoR)
The length of time between the achievement of criteria for response to treatment (first documented complete or partial response) and the first documented relapse or progression.
Time frame
up to 2 years3
Progression-free survival (PFS)
The time from the enrollment of a subject to the occurrence of (in any way) progression of disease or Death for any reason. patients with indeterminate recurrence or Death at the last follow-up, defined as the date of the last Investigation
Time frame
up to 2 years4
OS
The time from subject enrollment to Death caused by any reason. for patients lost to follow-up, the time of the last follow-up; for patients still alive at the end of study, the date of the end of follow-up.
Time frame
up to 2 yearsOther outcomes
1
To identify biomarkers
To identify biomarkers that may predict response to a combination regimen, biomarkers associated with progression to a more severe disease state, biomarkers that are sensitive to the development of Adverse event, biomarkers that provide evidence of the activity of the combination, or biomarkers that may enhance the understanding or understanding of the biology of the disease.
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov