DLBCL - Diffuse Large B Cell Lymphoma
Conditions
Brief summary
This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Treatment decisions will be made by the treating physician based on standard clinical practice and may include glofitamab monotherapy or glofitamab-based combination regimens, such as glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) or glofitamab plus polatuzumab-based therapy (Glofit-Pola). The study will collect baseline characteristics (including age, sex, medical history, and molecular subtype), treatment information, laboratory test results, adverse events, and survival follow-up data. Circulating tumor DNA (ctDNA) testing will be performed to assess minimal residual disease (MRD) in peripheral blood. When clinically indicated, cerebrospinal fluid samples may be collected to measure drug concentration. All personal information will be kept strictly confidential. Identifiable information will be removed and replaced with coded study numbers. Medical records will be maintained at the study site and accessed only by authorized research personnel. Representatives from the sponsor, ethics committee, or regulatory authorities may review study records as required. Study results will be published in aggregated form without including any information that could identify individual participants. Study data and personal information will be used solely for research purposes.
Interventions
None listed
Sponsors
Henan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must meet all of the following criteria: 1. Age ≥18 years at the time of treatment initiation. 2. Histologically or pathologically confirmed diffuse large B-cell lymphoma (DLBCL). 3. Patients with primary refractory disease or early relapse, defined as: Failure to achieve complete response (CR) after at least 4 cycles of first-line induction therapy, or Relapse confirmed by imaging within 12 months after achieving CR following first-line therapy. 4. Patients who plan to initiate a glofitamab-containing treatment regimen (either monotherapy or combination therapy) within 12 months after study initiation. 5. Willing and able to comply with study follow-up and data collection requirements.
Exclusion criteria
* Participants meeting any of the following criteria will be excluded: 1. Currently participating in, or planning to participate in, any interventional clinical trial. 2. Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study (e.g., inability to complete follow-up, safety concerns, or significant comorbidities).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 6 months | Overall response rate (ORR) is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to the Lugano criteria for lymphoma. The primary analysis will evaluate ORR at the end of treatment (EOT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CR Rate) | Up to 6 months after enrollment | Complete response (CR) rate is defined as the proportion of patients achieving complete response according to the Lugano criteria for lymphoma. |
| DoR | Up to 24 months | Duration of response (DoR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause. |
| Progression-Free Survival (PFS) | Up to 24 months | Progression-free survival (PFS) is defined as the time from initiation of glofitamab treatment to disease progression, relapse, or death from any cause. |
| Overall Survival (OS) | Up to 24 months | Overall survival (OS) is defined as the time from initiation of glofitamab treatment to death from any cause. |
| Incidence of Adverse Events | From treatment initiation to 3 months after the last dose | Safety will be evaluated by assessing the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and grade ≥3 adverse events according to CTCAE version 5.0. |
| Disease Control Rate (DCR) | Up to 6 months after enrollment | Disease control rate (DCR) is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to the Lugano criteria for lymphoma. |
| Time to Next Treatment (TTNT) | Up to 24 months | Time to next treatment (TTNT) is defined as the time from initiation of glofitamab therapy to the start of the next line of anti-lymphoma treatment. |
Countries
China
Contacts
CONTACTkeshu Dr zhou
Outcome results
None listed