Glofitamab treatment for patients with relapsed or refractory DLBCL before stem cell transplant

A Prospective Study of Glofitamab Bridging Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma.

This study is testing if Glofitamab can help patients with relapsed or hard-to-treat diffuse large B-cell lymphoma get ready for a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: Glofitamab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06682130 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Glofitamab as a bridging therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are preparing for autologous stem cell transplantation (ASCT). Participants aged 18 to 70 years, who have undergone at least two lines of systemic treatment, will be categorized into three groups based on their response to prior treatments. Group A will receive Glofitamab if they show partial response or are ctDNA positive, while Group B will proceed to ASCT if they achieve complete response and are ctDNA negative. Group C will be reassessed after Glofitamab treatment to determine their next steps based on their disease status.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with relapsed or refractory DLBCL who have received at least two lines of systemic treatment.

Not a fit: Patients with stable or progressive disease after second-line treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with relapsed or refractory DLBCL.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific regimen is novel in its application.

Eligibility criteria

Inclusion Criteria:

1. Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
2. Patients with R/R DLBCL who have received at least two lines of systemic treatment;
3. Age range: 18-70 years old, male or female not limited;
4. When the disease recurs or is difficult to treat, there are assessable lesions (lymph node diameter ≥ 1.0cm; or skin lesions assessable by physical examination);
5. Expected lifespan\>3 months;
6. No previous transplantation treatment has been performed;
7. ECOG score 0-1 points;
8. Appropriate organ function:

   Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal, total bilirubin\<2 times the upper limit of normal; Renal function: serum creatinine clearance rate ≥ 80 mL/min, creatinine\<160 umol/l; Pulmonary function: Without oxygen inhalation, SPO2\>90%, FEV1, FVC, and DLCO ≥ 50% predicted values;
9. Adequate bone marrow reserve is defined as:

   Hemoglobin ≥ 9g/dL, Platelet count ≥ 70 × 10 \^ 9/L, The absolute value of neutrophils is ≥ 1.0 × 10 \^ 9/L, If accompanied by bone marrow invasion, platelet count ≥ 50 × 10 \^ 9/L, absolute neutrophil count ≥ 0.75 × 10 \^ 9/L, The number of CD34+cells is ≥ 2.0 × 109/kg.
10. The patient has the ability to understand and is willing to provide written informed consent.
11. Subjects with fertility or potential for fertility must be willing to undergo contraception from the date of registration in this study until the study follow-up period.

Exclusion Criteria:

-1) Previously underwent autologous hematopoietic stem cell transplantation; 2) HIV infection and/or active hepatitis B or C; 3) Uncontrolled active infections; 4) Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal); 5) Existence of organic heart disease or severe arrhythmia, leading to clinical symptoms or abnormal heart function (NYHA functional class ≥ 2); 6) Simultaneously present other tumors that require treatment or intervention; 7) Previous or current history of vascular embolism; 8) Pregnant or lactating women; 9) In a state of severe immune suppression; 10) Other psychological conditions that hinder patients from participating in research or signing informed consent forms.

11\) According to the researcher's assessment, it is unlikely that the subjects will complete all the required study visits or procedures, including follow-up visits, or meet the requirements for participation in the study.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhengming Jin

Conditions Diffuse Large B-cell Lymphoma; Glofitamab; autologous stem cell transplantation