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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 : Completed
First Posted : August 29, 2005
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Janssen-Cilag International NV
Information provided by (Responsible Party):
Lymphoma Study Association

Study Description
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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 Drug: Doxorubicin Drug: Prednisone Drug: Cyclophosphamide Drug: Vindesine Drug: Bleomycin 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
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
Actual Study Start Date : January 8, 2006
Actual Primary Completion Date : April 18, 2011
Actual Study Completion Date : April 18, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
 Drug: Velcade
1.5 mg/m², D1, D5, 4 cycles

Drug: Doxorubicin
75 mg/m², D1, 4 cycles

Drug: Prednisone
60 mg/m², D1-D5, 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Complete response rate unconfirmed (CR+CR uncertain) [ Time Frame: 2 years ]
    percentage of patients with complete response

  2. Partial response (PR) rate [ Time Frame: 2 years ]
    percentage of patients with partial response

  3. Progression free survival (PFS) [ Time Frame: 2 years ]
    Duration of survival without progression

  4. Duration of response in complete responders (CR + CRu) [ Time Frame: 2 years ]
  5. Overall survival (OS) [ Time Frame: 2 years ]
    Percentage of patients alive

  6. Number of SAE [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


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

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Responsible Party: Lymphoma Study Association
ClinicalTrials.gov Identifier: NCT00136565    
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: August 23, 2018
Last Verified: August 2018
Keywords provided by Lymphoma Study Association:
peripheral T-cell lymphomas
bortezomib
ACVBP regimen
Additional relevant MeSH terms:
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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
Prednisone
Cyclophosphamide
Doxorubicin
Bortezomib
Bleomycin
 Vindesine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents