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
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Keep this study
Lead
The First Affiliated Hospital of Soochow University
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be 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.
Clareo Health | 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
