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NCT05910801PHASE2RECRUITING

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): a Phase II Study with Safety Lead-In

Sponsor: Academic and Community Cancer Research United + National Cancer Institute (NCI)

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Key Facts

Study type
INTERVENTIONAL
Conditions
Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Interventions
Biopsy, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
Enrollment
100 participants
Primary completion
Dec 2029
Study completion
Dec 2030
First posted
Jun 2023
Last updated
Nov 2024

Primary Endpoints (CT.gov)

Objective response rate

Time frame: Up to 5 years

Secondary Endpoints

Complete response rate

Duration of response

Progression free survival

Eligibility Criteria

Inclusion Criteria: * Age \>= 18 years old * Confirmed pathology diagnosis of mantle cell lymphoma (MCL) with t(11;14)(q13;q32) translocation or cyclin D1 overexpression NOTE: Patients with relapsed/refractory MCL after prior anti-CD19 therapy (such as chimeric antigen receptor \[CAR\] T-cell therapy) should have 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 * Relapsed or refractory disease, which is defined as patients with \>= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or venetoclax is allowed, provided there was no disease progression on lenalidomide or venetoclax * In the view of the treating physician, the patient is in need of treatment, for example, with lymphoma-related symptoms or cytopenia * Evaluable disease, which is defined as at least one lymph node or other type of lesion that has a size \>= 1.5 cm, or spleen size \>= 15 cm or white

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov