Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma

August 21, 2018 updated by: Lymphoma Study Association

A Phase II Study Evaluating the Efficacy and Safety of Bortezomib (Velcade™) Combined With ACVBP Regimen in Patients With Previously Untreated Peripheral T-cell Lymphoma

The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP [doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicentric, open-label, non-randomized, non-competitive clinical study, evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients aged from 18 to 65 years with peripheral T-lymphoma.

It is anticipated that 60 subjects will be enrolled over two years (from June 2005 to May 2007).

The duration of the treatment period is approximately 28 weeks and patients are followed until death.

The total duration of the study is expected to be 5 years (from June 2005 to May 2010).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Yvoir, Belgium
        • Groupe d'Etude des Lymphomes de l'Adulte
  • France
      • Pierre-Bénite cedex, France, 69495
        • Service d'Hématologie - Centre Hospitalier Lyon-Sud
      • Reims, France, 51092
        • Centre Hospitalier Robert Debre
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously untreated non-cutaneous peripheral T-cell lymphoma, including human T-cell lymphotropic virus type 1 (HTLV-1) related T-cell lymphoma, and natural killer (NK)-cell lymphoma.
  • Ages 18 to 65 years.
  • Life expectancy > 3 months.
  • Written informed consent.

Exclusion Criteria:

  • B-cell lymphoma or other subtype of T-cell lymphoma including anaplastic large cell lymphoma AKL(+), lymphoblastic lymphoma and primary cutaneous T-cell lymphoma.
  • Any previous therapy for lymphoma except for short-term corticosteroids before inclusion.
  • Inability to tolerate the ACVBP regimen according to investigator's judgement.
  • Positive serology for HIV.
  • Poor renal function (creatinin > 150 µmol/l within 14 days before enrollment), poor liver function (total bilirubin > 30 µmol/l, transaminases > 2.5 upper normal limit [UNL] within 14 days before enrollment), unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l within 14 days before enrollment, unless these abnormalities are related to the lymphoma.
  • Patient with >= grade 2 peripheral neuropathy non-related to lymphoma.
  • Any central nervous system (CNS) disease.
  • CNS or meningeal involvement by the lymphoma.
  • Any serious active disease or comorbidity according to the investigator's decision.
  • Any history of cancer during the last 5 years with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
  • Known hypersensitivity to bortezomib, boron or mannitol.
  • Contraindication to any cytotoxic drug contained in chemotherapy regimen.
  • Pregnant or lactating women or women of childbearing potential not willing to use an adequate method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of study.
  • Men not agreeing to take adequate contraceptive precautions during the study.
  • Treatment with investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Adult patient under tutelage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
Drug: Doxorubicin
75 mg/m², D1, 4 cycles
Drug: Cyclophosphamide
1200 mg/m², D1, 4 cycles
Drug: Vindesine
2 mg/m², D1, D5, 4 cycles
Drug: Bleomycin
10 mg, D1, D5, 4 cycles
Drug: Velcade
1.5 mg/m², D1, D5, 4 cycles
Drug: Prednisone
60 mg/m², D1-D5, 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: 2 years
percentage of patients alive with no event, events being defined as disease progression, institution of a new treatment for the lymphoma, relapse after complete response (CR), or death from any cause
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate unconfirmed (CR+CR uncertain)
Time Frame: 2 years
percentage of patients with complete response
2 years
Partial response (PR) rate
Time Frame: 2 years
percentage of patients with partial response
2 years
Progression free survival (PFS)
Time Frame: 2 years
Duration of survival without progression
2 years
Duration of response in complete responders (CR + CRu)
Time Frame: 2 years
2 years
Overall survival (OS)
Time Frame: 2 years
Percentage of patients alive
2 years
Number of SAE
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

Janssen-Cilag International NV

Investigators

  • Study Chair: Bertrand Coiffier, MD, Hospices Civils de Lyon, Lyon, France
  • Principal Investigator: Alain Delmer, MD, Centre Hospitalier Robert Debre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2006

Primary Completion (Actual)

April 18, 2011

Study Completion (Actual)

April 18, 2011

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria

August 26, 2005

First Posted (Estimate)

August 29, 2005

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNH05-1T
  • Janssen: i061-341-03
  • Eudract: 2005-001563-66

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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