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A Phase II Study of Oral Panobinostat (LBH589) and Rituximab to Treat Diffuse Large B Cell Lymphoma (DLBCL)

NCT01238692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-24

No results posted yet for this study

Summary

The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting. Tissue samples from accessible lymph nodes will be collected and banked before the start of the study treatment and after 15 days. Additionally, blood samples will be drawn and stored in the tissue biobank.

Conditions

Interventions

DRUG

LBH589

Patients randomized to both arms will receive oral LBH589, once-a-day, at a dose of 30 mg/day, on a three times-a-week (Monday, Wednesday and Friday) schedule as part of a 3 week (21 day) treatment cycle. Day one of each cycle will be on a Monday.

DRUG

Rituximab

Patients randomized to Arm B will receive IV rituximab at a dose of 375 mg/m2 in combination with oral LBH589. Rituximab should be administered on the same day as LBH589, after the patient has taken their LBH589 dose. The appropriate amount of solution should be withdrawn from the vial for the following calculation: Volume (mL) = BSA (m2) × dose (375 mg/m2) / concentration of reconstituted solution ml/mL (100 mg/10 mL and/or 500 mg/50 mL).

Sponsors & Collaborators

  • Quebec Clinical Research Organization in Cancer

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sarit Assouline

    lead OTHER

Principal Investigators

  • Sarit Assouline, MD · Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-01-31
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01238692 on ClinicalTrials.gov