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Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

NCT01449344 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-03-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Conditions

Interventions

DRUG

Rituximab

Rituximab 375mg/m² IV , day 1

DRUG

High dose Ara-C

Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3

DRUG

Dexamethasone

Dexamethasone 40 mg PO, day 1-4

DRUG

Bortezomib

Bortezomib 1.5 mg/m² IV, day 1 and 4

Sponsors & Collaborators

  • Klinikum der Universitaet Muenchen, Grosshadern

    collaborator OTHER

  • ClinAssess GmbH

    collaborator INDUSTRY

  • GELARC Service de Pharmacovigilance, Pierre Benite

    collaborator UNKNOWN

  • Prof. Dr. M. Dreyling (co-chairman)

    lead OTHER

Principal Investigators

  • Martin Dreyling, MD · Klinikum der Universität München, Grosshadern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-09
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01449344 on ClinicalTrials.gov