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Withdrawn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

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 ]

Related Studies