Relapsed/Refractory Diffuse Large B Cell LymphomaPhase 2NCT07621406
Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study testing Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.) in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of tafasitamab combined with lenalidomide plus standard immunochemotherapy, followed by sequential autologous stem cell transplantation (ASCT), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed/Refractory Diffuse Large B Cell Lymphoma
- What is being tested?
- Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- 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
- Age ≥18 years;
- Pathologically confirmed diagnosis of relapsed or refractory DLBCL;
- Patients must meet the following criteria:
- Definition of relapsed or refractory: Refractory: Patients who did not achieve remission (≥PR) with the most recent systemic therapy; Relapsed/progressive: Patients who developed new lesions or experienced a ≥50% increase in existing lesions (based on the Lugano 2014 classification for non-Hodgkin lymphoma) following the most recent systemic therapy;
- At least one bidimensionally measurable lesion, defined as a lesion with the longest dimension >1.5 cm and perpendicular diameter >1.0 cm on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI), confirmed as positive by PET-CT;
- For DLBCL, prior receipt of at least one line but no more than four lines of systemic therapy, which must include CD20-targeted therapy;
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- ECOG performance status score of 0-2.
- Meet the criteria for autologous hematopoietic stem cell transplantation (ASCT) and be willing to undergo ASCT;
- Adequate major organ function:
- Liver function: ALT/AST <3× upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L;
- Renal function: Creatinine <220 μmol/L;
- Pulmonary function: Oxygen saturation ≥95% without supplemental oxygen;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%;
- Transplant comorbidity index score ≤3.
- As judged by the investigator, patients must:
- Be willing to receive adequate prophylaxis and/or treatment for thromboembolic events;
- Be able to understand and sign informed consent, and comply with all study-related procedures, medication use, and evaluations;
- Have no history of non-adherence to medical prescriptions or be deemed by the investigator to have no potential for non-adherence;
- Be able to understand and comply with pregnancy prevention requirements and reasons, the pregnancy prevention risk management plan, and provide written confirmation.
Who cannot join
- Pregnant (positive urine/serum pregnancy test) or lactating women;
- Men or women with plans for conception within 1 year;
- Inability to guarantee effective contraceptive measures (e.g., condoms, contraceptives) within 1 year after enrollment;
- Uncontrolled infectious disease within 4 weeks prior to enrollment;
- Active hepatitis B or C virus infection;
- Severe autoimmune disease or immunodeficiency disorder;
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- History of allergy to macromolecular biologic drugs such as antibodies or cytokines;
- Participation in another clinical trial within 6 weeks prior to enrollment;
- Systemic use of corticosteroids within 4 weeks prior to enrollment (excluding patients using inhaled corticosteroids);
- Psychiatric illness;
- Substance abuse/dependence;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma, Prospective Phase II Clinical Study
This study aims to evaluate the efficacy and safety of tafasitamab combined with lenalidomide plus standard immunochemotherapy, followed by sequential autologous stem cell transplantation (ASCT), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
- Being tested
- Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.)
- Keywords
- tafasitamab, lenalidomide, Relapsed/Refractory Diffuse Large B-cell lymphoma
- 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.
Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.)Drug
Eligible patients with transplant-eligible relapsed/refractory DLBCL will receive 2-4 cycles (21 days per cycle) of tafasitamab combined with lenalidomide and standard immunochemotherapy regimens (such as R-ICE, R-DHAP, R-GDP, etc.). If the patient achieves a complete response (CR) or partial response (PR) on efficacy assessment, they will proceed to autologous stem cell transplantation (ASCT). Following ASCT, eligible patients may receive maintenance therapy with tafasitamab ± lenalidomide (28 days per cycle) for up to one year.
| Study group | Role | What they receive |
|---|---|---|
| Tafasitamab + Lenalidomide + Standard Immunotherapy Regimens (e.g., R-ICE, R-DHAP, R-GDP, etc.)+ASCT | Experimental | Not described Receives: Drug: Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to ASCT
Secondary outcomes (1)
CRR
Measured: 2 years after ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Diffuse Large B Cell LymphomaStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621406
- Sponsor's protocol ID
- TAFA-LEN-ASCT
- Status last verified
- Jan 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma, Prospective Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07621406
- Acronym / sponsor ID
- TAFA-LEN-ASCT
- Keywords
- tafasitamab, lenalidomide, Relapsed/Refractory Diffuse Large B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (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.
This study aims to evaluate the efficacy and safety of tafasitamab combined with lenalidomide plus standard immunochemotherapy, followed by sequential autologous stem cell transplantation (ASCT), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafasitamab + Lenalidomide + Standard Immunotherapy Regimens (e.g., R-ICE, R-DHAP, R-GDP, etc.)+ASCT | Experimental | Drug: Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years;
- Pathologically confirmed diagnosis of relapsed or refractory DLBCL;
- Definition of relapsed or refractory: Refractory: Patients who did not achieve remission (≥PR) with the most recent systemic therapy; Relapsed/progressive: Patients who developed new lesions or experienced a ≥50% increase in existing lesions (based on the Lugano 2014 classification for non-Hodgkin lymphoma) following the most recent systemic therapy;
- At least one bidimensionally measurable lesion, defined as a lesion with the longest dimension >1.5 cm and perpendicular diameter >1.0 cm on contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI), confirmed as positive by PET-CT;
- For DLBCL, prior receipt of at least one line but no more than four lines of systemic therapy, which must include CD20-targeted therapy;
Key exclusion criteria (12 listed)
- Pregnant (positive urine/serum pregnancy test) or lactating women;
- Men or women with plans for conception within 1 year;
- Inability to guarantee effective contraceptive measures (e.g., condoms, contraceptives) within 1 year after enrollment;
- Uncontrolled infectious disease within 4 weeks prior to enrollment;
- Active hepatitis B or C virus infection;
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 |
|---|---|---|
| Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.)Eligible patients with transplant-eligible relapsed/refractory DLBCL will receive 2-4 cycles (21 days per cycle) of tafasitamab combined with lenalidomide and standard immunochemotherapy regimens (such as R-ICE, R-DHAP, R-GDP, etc.). If the patient achieves a complete response (CR) or partial response (PR) on efficacy assessment, they will proceed to autologous stem cell transplantation (ASCT). Following ASCT, eligible patients may receive maintenance therapy with tafasitamab ± lenalidomide (28 days per cycle) for up to one year. | Drug | Tafasitamab + Lenalidomide + Standard Immunotherapy Regimens (e.g., R-ICE, R-DHAP, R-GDP, etc.)+ASCT |
Primary outcome
overall response rate
Time frame: at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to ASCT
1 secondary outcome
CRR
Time frame: 2 years after ASCT
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 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.) in people with Relapsed/Refractory Diffuse Large B Cell Lymphoma, 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 19 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to 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 2 Jun 2026.