We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00136565
Recruitment Status : Unknown
Verified November 2007 by Lymphoma Study Association.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2005
Last Update Posted : November 8, 2007
Information provided by:

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Peripheral T-Cell Lymphoma Drug: Velcade + ACVBP regimen Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Efficacy measured by event-free survival (EFS), events being defined as disease progression, institution of a new treatment for the lymphoma, relapse after complete response (CR), or death from any cause

Secondary Outcome Measures :
  1. Efficacy
  2. Response rate to treatment: complete response (CR + complete response unconfirmed [CRu]) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
  3. Progression free survival (PFS)
  4. Duration of response in complete responders (CR + CRu)
  5. Overall survival (OS)
  6. Safety: safety evaluations will be based on collection of adverse events (AEs), physical examination findings and clinical laboratory results.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136565

Groupe d'Etude des Lymphomes de l'Adulte
Mont-Godinne, Belgium
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Hospitalier Robert Debré
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Lymphoma Study Association
Janssen-Cilag International NV
Study Chair: Bertrand Coiffier, MD Hospices Civils de Lyon, Lyon, France
Principal Investigator: Alain Delmer, MD Centre Hospitalier Robert Debré
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00136565     History of Changes
Other Study ID Numbers: LNH05-1T
Janssen: i061-341-03
Eudract: 2005-001563-66
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: November 2007

Keywords provided by Lymphoma Study Association:
peripheral T-cell lymphomas
ACVBP regimen

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents