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A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma

NCT01929265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2017-10-13

No results posted yet for this study

Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

Conditions

  • Indolent Non-follicular
  • Non-Hodgkin's Lymphoma

Interventions

DRUG

Bendamustine

INDUCTION PHASE Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week): Rituximab: 375 mg/sqm iv, day 1\* Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice Repeat cycles every 28 days for a total of 4 cycles \*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8. CONSOLIDATION PHASE Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week): Rituximab: 375 mg/sqm iv day 1 Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice Rituximab two monthly doses Rituximab: 375 mg/sqm iv week 24 and 28

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Luca Baldini, Prof. · UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2015-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929265 on ClinicalTrials.gov