POLA+BR for Relapsed or Refractory DLBCL

Sponsor
University of Colorado, Denver
Study ID
NCT04535102
Phase
PHASE2
Status
Withdrawn

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin is an ADC designed for the targeted delivery of MMAE(mono-methyl auristatin E), a potent microtubule inhibitor to lymphoma cells expressing CD79b. MMAE has a mechanism of action that is similar to that of vincristine.

Study Details

This is a phase II multicenter, open-label study of polatuzumab vedotin administered by IV infusion in combination with standard doses of bendamustine (B) and rituximab (R) in transplant-eligible patients with relapsed or refractory DLBCL. A total of 22 patients will be enrolled over a period of 2 years through the University of Colorado and additional study sites if applicable. Study treatment will be given in 21-day cycles for patients with DLBCL.

Key Dates

First listed
Sep 1, 2020
Start date
Jan 29, 2021
Status verified
May 2022
Primary completion
Mar 17, 2022
Completion
Mar 17, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab + BR (minimum 3 cycles)
    Patients will be treated with a minimum of 3 cycles up to a maximum six cycles to optimize response prior to ASCT (stem cell transplant) per investigator discretion

Primary Outcome Measure

Complete response at primary response [ Time Frame: 3 weeks after last dose of study medication ]

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