Diffuse Large B-cell Lymphoma(DLBCL)Phase 2ASCT DLBCLNCT06682130
Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL
A Phase 2 study testing Group A：Patients with PR or ctDNA positivity after salvage treatment, Group B: Patients with CR and ctDNA negative after salvage treatment and Group C: Patients with SD/PD after posterior treatment in people with Diffuse Large B-cell Lymphoma(DLBCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma(DLBCL)
- What is being tested?
- Group A：Patients with PR or ctDNA positivity after salvage treatment, Group B: Patients with CR and ctDNA negative after salvage treatment and Group C: Patients with SD/PD after posterior treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 10 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
- Patients with R/R DLBCL who have received at least two lines of systemic treatment;
- Age range: 18-70 years old, male or female not limited;
- 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);
- Expected lifespan>3 months;
- No previous transplantation treatment has been performed;
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- ECOG score 0-1 points;
- 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;
- 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.
- The patient has the ability to understand and is willing to provide written informed consent.
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Zhengming Jin, 67781856, jinzhengming519519@163.com
Changju Qu, 67781856, qcj310@163.com
About this study
Official title: A Prospective Study of Glofitamab Bridging Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma.
The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.
Read the detailed description
This study seeks to include patients aged 18 to 70 years with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have undergone at least a second-line systemic treatment, excluding those with prior resistance to Glofitamab. Based on their disease status following the second-line treatment, participants will be categorized into three groups: A, B, and C. Group A will consist of patients who exhibit partial response (PR) or are circulating tumor DNA (ctDNA) positive after second-line treatment and are planning to undergo autologous stem cell transplantation (ASCT) or Glofitamab as a bridging therapy to ASCT. Group B will include patients who achieve complete response (CR) and are ctDNA negative post-second-line treatment, and they will receive ASCT as consolidation therapy. Patients in Group B who achieved CR and were ctDNA negative following second-line treatment will proceed directly to ASCT consolidation therapy. In Group C, patients who exhibited stable disease (SD) or progressive disease (PD) after second-line treatment were reassessed following two cycles of Glofitamab. Those who attained PR subsequently underwent ASCT consolidation therapy, whereas patients achieving CR had the option to either undergo ASCT or continue with Glofitamab maintenance therapy. Patients with SD or PD were excluded from the study. Patients exhibiting SD or PD were excluded from the cohort. Individuals who have successfully undergone autologous transplantation and subsequent maintenance therapy with Glofitamab will be monitored for assessments of efficacy and survival outcomes.
- Conditions
- Diffuse Large B-cell Lymphoma(DLBCL)
- Being tested
- Group A：Patients with PR or ctDNA positivity after salvage treatment, Group B: Patients with CR and ctDNA negative after salvage treatment, Group C: Patients with SD/PD after posterior treatment
- Keywords
- Glofitamab, autologous stem cell transplantation
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A：Patients with PR or ctDNA positivity after salvage treatmentDrug
- Immunotargeted therapy
- Ottuzumab introvenous infusion, 1000mg day1;
- Glofitamab introvenous infusion Group A: 2.5mg day8
- Autologous stem cell transplantation SEAM regimen
- Simustine 250mg/m2 orally, day1
- Etoposide 200mg/m2 intravenous infusion, day2-5
- Cytarabine 400mg/m2 intravenous infusion, day2-5
- Metformin 140mg/m2 intravenous infusion, day6; Patients in Group A who intend to receive Glofitamab+ASCT will receive Glofitamab 2.5mg on day8 and start ASCT pretreatment on day15.
Group B: Patients with CR and ctDNA negative after salvage treatmentProcedure or surgery
Group B patients initiated ASCT treatment directly after evaluating the efficacy of salvage treatment
Group C: Patients with SD/PD after posterior treatmentDrug
- Immunotargeted therapy
- Ottuzumab introvenous infusion, 1000mg day1;
- Glofitamab introvenous infusion Group C: cycle1 2.5mg day8, 10mg day15 cycle2 30mg day21
- Autologous stem cell transplantation SEAM regimen
- Simustine 250mg/m2 orally, day1
- Etoposide 200mg/m2 intravenous infusion, day2-5
- Cytarabine 400mg/m2 intravenous infusion, day2-5
- Metformin 140mg/m2 intravenous infusion, day6;
After two treatment cycles with Glofitamab, patients in group C had a PET-CT to assess efficacy. Those with partial remission proceeded to ASCT consolidation, those with complete remission chose between ASCT or Glofitamab maintenance, and those with stable disease or progressive disease exited the trial.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab bridging ASCT Regimen | Experimental | After at least second-line treatment, patients will be divided into three groups based on their disease status: Group A includes patients with partial response (PR) or ctDNA positivity who plan to receive ASCT or Glofitamab (specification: 10 mg per tube; dosage: 2.5 mg on day 8) as a bridge to ASCT; Group B includes patients with complete response (CR) and ctDNA negativity who will proceed directly to ASCT; Group C includes patients with stable or progressive disease (SD/PD) who will be assessed after two cycles of Glofitamab (Specification: 10mg per tube;Dosage: cycle 1: 2.5mg d8；10mg d15；cycle 2: 30mg d21). Those achieving PR will undergo ASCT, those with CR can choose ASCT or continue Glofitamab, and those with SD/PD will be removed from the group. Receives: Drug: Group A：Patients with PR or ctDNA positivity after salvage treatment; Procedure: Group B: Patients with CR and ctDNA negative after salvage treatment; Drug: Group C: Patients with SD/PD after posterior treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate(CRR)
The rate of patients who achieved CR after treatment with Glofitamab bridging ASCT Regimen
Measured: At the end of 3 months after ASCT
Secondary outcomes (4)
Main adverse reactions
The safety and tolerability of the therapeutic regimen measured by the major adverse events.
Measured: Start from the first day of Immunotargeted therapy to 1 month after treatment with Glofitamab bridging ASCT Regimen
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment with Glofitamab bridging ASCT Regimen
Measured: At the end of 3 months after ASCT.
2-year progression-free survival(PFS)
PFS will be assessed from the first day of Immunotargeted therapy to date of progression, relapse, death or end of follow-up.
Measured: From enrollment to 2 year after the treatment of last patient
2-year overall survival(OS)
OS will be assessed from the first day of Immunotargeted therapy to date of death or end of follow-up.
Measured: From enrollment to 2 year after the treatment of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Nov 2024
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma(DLBCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682130
- Sponsor's protocol ID
- 2024378
- Acronym
- ASCT DLBCL
- Status last verified
- Jul 2025
- First submitted
- 7 Nov 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Glofitamab Bridging Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT06682130
- Acronym / sponsor ID
- ASCT DLBCL / 2024378
- Conditions
- Diffuse Large B-cell Lymphoma(DLBCL)
- Keywords
- Glofitamab, autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2029 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.
Detailed description
This study seeks to include patients aged 18 to 70 years with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have undergone at least a second-line systemic treatment, excluding those with prior resistance to Glofitamab. Based on their disease status following the second-line treatment, participants will be categorized into three groups: A, B, and C. Group A will consist of patients who exhibit partial response (PR) or are circulating tumor DNA (ctDNA) positive after second-line treatment and are planning to undergo autologous stem cell transplantation (ASCT) or Glofitamab as a bridging therapy to ASCT. Group B will include patients who achieve complete response (CR) and are ctDNA negative post-second-line treatment, and they will receive ASCT as consolidation therapy. Patients in Group B who achieved CR and were ctDNA negative following second-line treatment will proceed directly to ASCT consolidation therapy. In Group C, patients who exhibited stable disease (SD) or progressive disease (PD) after second-line treatment were reassessed following two cycles of Glofitamab. Those who attained PR subsequently underwent ASCT consolidation therapy, whereas patients achieving CR had the option to either undergo ASCT or continue with Glofitamab maintenance therapy. Patients with SD or PD were excluded from the study. Patients exhibiting SD or PD were excluded from the cohort. Individuals who have successfully undergone autologous transplantation and subsequent maintenance therapy with Glofitamab will be monitored for assessments of efficacy and survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab bridging ASCT Regimen | Experimental | Drug: Group A：Patients with PR or ctDNA positivity after salvage treatment, Procedure: Group B: Patients with CR and ctDNA negative after salvage treatment, Drug: Group C: Patients with SD/PD after posterior treatmentAfter at least second-line treatment, patients will be divided into three groups based on their disease status: Group A includes patients with partial response (PR) or ctDNA positivity who plan to receive ASCT or Glofitamab (specification: 10 mg per tube; dosage: 2.5 mg on day 8) as a bridge to ASCT; Group B includes patients with complete response (CR) and ctDNA negativity who will proceed directly to ASCT; Group C includes patients with stable or progressive disease (SD/PD) who will be assessed after two cycles of Glofitamab (Specification: 10mg per tube;Dosage: cycle 1: 2.5mg d8；10mg d15；cycle 2: 30mg d21). Those achieving PR will undergo ASCT, those with CR can choose ASCT or continue Glofitamab, and those with SD/PD will be removed from the group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases;
- Patients with R/R DLBCL who have received at least two lines of systemic treatment;
- Age range: 18-70 years old, male or female not limited;
- 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);
- Expected lifespan>3 months;
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A：Patients with PR or ctDNA positivity after salvage treatment1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group A: 2.5mg day8 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; Patients in Group A who intend to receive Glofitamab+ASCT will receive Glofitamab 2.5mg on day8 and start ASCT pretreatment on day15. | Drug | Glofitamab bridging ASCT Regimen |
| Group B: Patients with CR and ctDNA negative after salvage treatmentGroup B patients initiated ASCT treatment directly after evaluating the efficacy of salvage treatment | Procedure or surgery | Glofitamab bridging ASCT Regimen |
| Group C: Patients with SD/PD after posterior treatment1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group C: cycle1 2.5mg day8, 10mg day15 cycle2 30mg day21 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; After two treatment cycles with Glofitamab, patients in group C had a PET-CT to assess efficacy. Those with partial remission proceeded to ASCT consolidation, those with complete remission chose between ASCT or Glofitamab maintenance, and those with stable disease or progressive disease exited the trial. | Drug | Glofitamab bridging ASCT Regimen |
Primary outcome
Complete remission rate(CRR)
Time frame: At the end of 3 months after ASCT
The rate of patients who achieved CR after treatment with Glofitamab bridging ASCT Regimen
4 secondary outcomes
Main adverse reactions
Time frame: Start from the first day of Immunotargeted therapy to 1 month after treatment with Glofitamab bridging ASCT Regimen
Overall response rate(ORR)
Time frame: At the end of 3 months after ASCT.
2-year progression-free survival(PFS)
Time frame: From enrollment to 2 year after the treatment of last patient
2-year overall survival(OS)
Time frame: From enrollment to 2 year after the treatment of last patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group A：Patients with PR or ctDNA positivity after salvage treatment, Group B: Patients with CR and ctDNA negative after salvage treatment and Group C: Patients with SD/PD after posterior treatment in people with Diffuse Large B-cell Lymphoma(DLBCL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengming Jin (67781856, jinzhengming519519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate(CRR) (time frame: At the end of 3 months after ASCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.