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

NCT00136565 | Completed Phase 2

• 3 other identifiers: LNH05-1TJanssen: i061-341-03Eudract: 2005-001563-66
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 5

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).

Conditions

Peripheral T-cell Lymphoma

Keywords

peripheral T-cell lymphomas; bortezomib; ACVBP regimen

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  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 Outcomes (6)

• Complete response rate unconfirmed (CR+CR uncertain)

  2 years

• Partial response (PR) rate

  2 years

• Progression free survival (PFS)

  2 years

• Duration of response in complete responders (CR + CRu)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Experimental

EXPERIMENTAL

Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone

Drug: Velcade; Drug: Doxorubicin; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Vindesine; Drug: Bleomycin

Interventions

Velcade DRUG

1.5 mg/m², D1, D5, 4 cycles

Experimental

Doxorubicin DRUG

75 mg/m², D1, 4 cycles

Experimental

Prednisone DRUG

60 mg/m², D1-D5, 4 cycles

Experimental

Cyclophosphamide DRUG

1200 mg/m², D1, 4 cycles

Experimental

Vindesine DRUG

2 mg/m², D1, D5, 4 cycles

Experimental

Bleomycin DRUG

10 mg, D1, D5, 4 cycles

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• B-cell lymphoma or other subtype of T-cell lymphoma including anaplastic large cell lymphoma AKL(+), lymphoblastic lymphoma and primary cutaneous T-cell lymphoma.
• 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.

Sponsors & Collaborators

• Lymphoma Study Association: lead
• Janssen-Cilag International NV: collaborator

Study Sites (5)

Groupe d'Etude des Lymphomes de l'Adulte

Yvoir, Belgium

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Robert Debré

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (3)

• Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.

  PMID: 15613697 BACKGROUND

• O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. doi: 10.1200/JCO.2005.02.050. Epub 2004 Dec 21.

  PMID: 15613699 BACKGROUND

• Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.

  PMID: 15917644 BACKGROUND

Related Links

• Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Bortezomib; Doxorubicin; Prednisone; Cyclophosphamide; Vindesine; Bleomycin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Bertrand Coiffier, MD

  Hospices Civils de Lyon, Lyon, France

  STUDY CHAIR

• Alain Delmer, MD

  Centre Hospitalier Robert Debré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: January 8, 2006
• Primary Completion: April 18, 2011
• Study Completion: April 18, 2011
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

BE (1); FR (4)