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NCT05910801 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United.

Compiled by PlainTrial · August 8, 2026

Recruiting
Registry status: Phase 2
Development phase: 100
Enrollment target: 2
Study locations

NCT05910801: Recruiting Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, sponsored by Academic and Community Cancer Research United.

NCT05910801 is a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma that is actively recruiting participants, run by Academic and Community Cancer Research United. The registered enrollment target is 100 participants, above the 34-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (194% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05910801, a Phase 2 study of Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, is actively recruiting participants, sponsored by Academic and Community Cancer Research United.

RECRUITING
Registry status: Phase 2
Development phase: 100 participants
Enrollment target: 2
Study locations

Study Summary

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.

Primary Outcome

A response is defined to be either a partial metabolic response (PMR) or complete metabolic response (CMR) by positron emission tomography (PET) or a partial response (PR) or complete response (CR) by computed tomography (CT) noted as the objective status using Lugano criteria. Objective response rate is defined as the proportion of evaluable patients who achieve response while on treatment. Estimate and corresponding 95% confidence intervals will be calculated according to the approach of Duffy

Conditions Studied

Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma

Interventions

PROCEDURE Biospecimen Collection
PROCEDURE Bone Marrow Aspiration
PROCEDURE Bone Marrow Biopsy
PROCEDURE Computed Tomography
PROCEDURE Biopsy

Study Locations (2)

Minnesota

Mayo Clinic in Rochester - Rochester

Texas

M D Anderson Cancer Center - Houston

Trial Details

Field	Value
Enrollment Target	100 participants
Start Date	2024-01-04
Est. Completion	2030-12-30
Phase	Phase 2

Academic and Community Cancer Research United

42 total trials

What NCT05910801 shows while recruiting

NCT05910801 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 27 other Recurrent Mantle Cell Lymphoma trials with a reported enrollment target (194% higher).

The record links to 2 conditions, with Recurrent Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05910801 reports a single indexed study location in Minnesota, Texas.

Frequently Asked Questions

What is clinical trial NCT05910801 about?

NCT05910801 is a clinical study titled "Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma". 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 in...

What is the current status of trial NCT05910801?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-01-04. Estimated completion is 2030-12-30.

What conditions does trial NCT05910801 study?

This clinical trial studies the following conditions: Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma.

What interventions are being tested in trial NCT05910801?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT05910801?

This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05910801 being conducted?

This trial has 2 study locations across Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Mantle Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05910801's enrollment target sits among peer trials

100 2nd of 27 the highest of 27 other Recurrent Mantle Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05910801, the US trial registry maintained by the National Library of Medicine. NCT05910801 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.