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

June 1, 2026 updated by: The First Affiliated Hospital of Soochow University

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Age ≥18 years;

Pathologically confirmed diagnosis of relapsed or refractory DLBCL;

Patients must meet the following criteria:

  1. 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;
  2. 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;
  3. For DLBCL, prior receipt of at least one line but no more than four lines of systemic therapy, which must include CD20-targeted therapy;
  4. 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:

  1. Liver function: ALT/AST <3× upper limit of normal (ULN) and total bilirubin ≤34.2 μmol/L;
  2. Renal function: Creatinine <220 μmol/L;
  3. Pulmonary function: Oxygen saturation ≥95% without supplemental oxygen;
  4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥40%;
  5. Transplant comorbidity index score ≤3.

As judged by the investigator, patients must:

  1. Be willing to receive adequate prophylaxis and/or treatment for thromboembolic events;
  2. Be able to understand and sign informed consent, and comply with all study-related procedures, medication use, and evaluations;
  3. Have no history of non-adherence to medical prescriptions or be deemed by the investigator to have no potential for non-adherence;
  4. Be able to understand and comply with pregnancy prevention requirements and reasons, the pregnancy prevention risk management plan, and provide written confirmation.

Exclusion Criteria

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tafasitamab + Lenalidomide + Standard Immunotherapy Regimens (e.g., R-ICE, R-DHAP, R-GDP, etc.)+ASCT
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to ASCT
at the end of tafasitamab and lenalidomide combined with standard immunotherapy regimen prior to ASCT

Secondary Outcome Measures

Outcome Measure
Time Frame
CRR
Time Frame: 2 years after ASCT
2 years after ASCT

Other Outcome Measures

Outcome Measure
Time Frame
EFS
Time Frame: 2 years after ASCT
2 years after ASCT
OS
Time Frame: 2 years after ASCT
2 years after ASCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAFA-LEN-ASCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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