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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Janssen-Cilag International NV
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00136565
First received: August 26, 2005
Last updated: November 6, 2007
Last verified: November 2007
  Purpose

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 Intervention Phase
Peripheral T-Cell Lymphoma
Drug: Velcade + ACVBP regimen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

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

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: November 2008
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136565

Locations
Belgium
Groupe d'Etude des Lymphomes de l'Adulte
Mont-Godinne, Belgium
France
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
Investigators
Study Chair: Bertrand Coiffier, MD Hospices Civils de Lyon, Lyon, France
Principal Investigator: Alain Delmer, MD Centre Hospitalier Robert Debré
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00136565     History of Changes
Other Study ID Numbers: LNH05-1T, Janssen: i061-341-03, Eudract: 2005-001563-66
Study First Received: August 26, 2005
Last Updated: November 6, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bleomycin
Doxorubicin
Bortezomib
Cyclophosphamide
Prednisone
Vindesine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014