Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Bortezomib-Rituximab-Bendamustine — DRUG
  Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22\* Rituximab: 375 mg/sqm i.v. day 1\*\* Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles \*In case of toxicity is omitted \*\*In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8

Study Details

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia.

Key Dates

Start date

Jun 30, 2014

Status verified

Nov 2020

Primary completion

Nov 30, 2017

Completion

Jul 22, 2020

Study Design

Enrollment

38 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bortezomib-Rituximab-Bendamustine
  Bortezomib-Rituximab-Bendamustine (BRB) combination in patients with relapsed/refractory lymphoplasmocytic/lymphoplasmocytoid lymphoma/Waldenstrom macroglobulinemia after one line of therapy.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 18 months ]