MedTrace Logo

Immunochemotherapy With Rituximab-Bendamustine-Cytarabine (R-BAC) for Patients With Mantle Cell Lymphoma

NCT00992134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-09-26

No results posted yet for this study

Summary

The objective of the study is to demonstrate the safety, tolerability, and activity of Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL) aged 65 years or more, as well as in younger patients who are not eligible for intensive regimens including/not including autologous transplantation.

Conditions

  • Lymphoma, Mantle-Cell

Interventions

DRUG

Rituximab, Bendamustine, Cytarabine

Rituximab IV 375 mg/m2 on day 1. Bendamustine IV 70 mg/m2 over a 30-60 minute infusion on day 1 and 2. Cytarabine IV 800 mg/m2, over a 2-hour infusion, 2 hours after Bendamustine, on Day 1, 2, and 3. Four to six cycles. Recycle every 28 days.

Sponsors & Collaborators

  • St. Bortolo Hospital

    lead OTHER

Principal Investigators

  • Carlo Visco, MD · Department of Hematology, San Bortolo Hospital, Vicenza

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT00992134 on ClinicalTrials.gov