Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma

Conditions

• Diffuse Large B-cell Lymphoma Refractory
• Follicular B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brentuximab Vedotin — DRUG
• Rituximab — DRUG
• Bendamustine — DRUG

Study Details

This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

Key Dates

Start date

Oct 31, 2015

Status verified

Sep 2018

Primary completion

Sep 30, 2017

Completion

Sep 30, 2017

Study Design

Enrollment

25 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brentuximab Vedotin
  Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.
• Active Comparator: Rituximab,Bendamustine control
  Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Approximately 1 year ]

Locations (22)

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