OncoMatch/Clinical Trials/NCT05910801
Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Is NCT05910801 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Tafasitamab and Lenalidomide for recurrent mantle cell lymphoma.
Treatment: Lenalidomide · Tafasitamab · Venetoclax — This phase II trial tests how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory). Tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving tafasitamab, lenalidomide and venetoclax together may kill cancer cells more efficiently in patients with relapsed or refractory mantle cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Endocrine / hormonal
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
cyclin D1 overexpression
Required: IGH t(11;14)(q13;q32) translocation
t(11;14)(q13;q32) translocation
Required: CD19 preserved expression
confirmed preserved expression of CD19, unless a biopsy is not feasible or associated with a high risk of complications in the treating physician's opinion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: autologous stem cell transplant
Autologous stem cell transplant <= 90 days prior to registration
Cannot have received: allogeneic stem cell transplant
Allogeneic stem cell transplant
Cannot have received: anti-CD19 CAR-T cell therapy
Anti-CD19 CAR T-cell therapy <= 90 days prior to registration
Lab requirements
Blood counts
ANC >= 1500/mm^3; Platelet count >= 75,000/mm^3 (>= 50,000/mm^3 if bone marrow involvement by MCL or hypersplenism); Hemoglobin > 8.0 g/dL
Kidney function
Calculated creatinine clearance > 60 ml/min using Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 × ULN (or <= 3 × ULN if parenchymal liver involvement with MCL or Gilbert's disease); ALT and AST <= 3 × ULN (or <= 5 × ULN if parenchymal liver involvement with MCL)
ANC >= 1500/mm^3; Platelet count >= 75,000/mm^3 (>= 50,000/mm^3 if bone marrow involvement by MCL or hypersplenism); Hemoglobin > 8.0 g/dL; aPTT or PTT <= 1.5 × ULN; PT or INR <= 1.5 × ULN; Total bilirubin <= 1.5 × ULN (or <= 3 × ULN if parenchymal liver involvement with MCL or Gilbert's disease); ALT and AST <= 3 × ULN (or <= 5 × ULN if parenchymal liver involvement with MCL); Calculated creatinine clearance > 60 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05910801 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous stem cell transplant, allogeneic stem cell transplant, anti-CD19 CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require IGH?
Yes, IGH t(11;14)(q13;q32) translocation is a required biomarker for enrollment.
Does this trial require CD19?
Yes, CD19 preserved expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages