Efficacy of Polatuzumab, Bendamustine and Rituximab in Patients With Relapsed/ Refractory Mantle Cell Lymphoma

Sponsor
Medical University of Vienna
Study ID
NCT05868395
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab, bendamustin und rituximab — DRUG
    * Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle * Bendamustine 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle * Rituximab 375 mg/m2 i.v. on day 1 of each cycle * Each cycle is 21 days long * Up to 6 cycles per patients planned

Study Details

Polatuzumab, bendamustine and rituximab in patients with relapsed/ refractory mantle cell lymphoma

Key Dates

Start date
Jan 2, 2024
Status verified
May 2024
Primary completion
May 24, 2027
Completion
May 24, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab, bendamustine and rituximab
    Polatuzumab vedotin 1.8 mg/kg i.v. on day 2 of cycle 1, then on day 1 of each subsequent cycle, bendamustine 90 mg/m2 i.v. day 2 \& 3 of cycle 1, then on day 1 \& 2 of each subsequent cycle and rituximab 375 mg/m2 i.v. on day 1 of each cycle every 3 weeks.

Primary Outcome Measure

Objective response rate [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause or treatmentdiscontinuation from any other reason, whichever came first, assessedup to 36 months] ]

Central Contacts

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