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

NCT07621406 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TAFA-LEN-ASCT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Relapsed/Refractory Diffuse Large B Cell Lymphoma

Keywords

tafasitamab; lenalidomide; Relapsed/Refractory Diffuse Large B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to ASCT

Secondary Outcomes (1)

• CRR

  2 years after ASCT

Other Outcomes (2)

• EFS

  2 years after ASCT

• OS

  2 years after ASCT

Study Arms (1)

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.)

Interventions

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.

Tafasitamab + Lenalidomide + Standard Immunotherapy Regimens (e.g., R-ICE, R-DHAP, R-GDP, etc.)+ASCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-01

Locations

CN (1)