search
Back to results

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

Primary Purpose

Peripheral T-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Velcade
Doxorubicin
Prednisone
Cyclophosphamide
Vindesine
Bleomycin
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring peripheral T-cell lymphomas, bortezomib, ACVBP regimen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe d'Etude des Lymphomes de l'Adulte
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
  • Centre Hospitalier Robert Debré
  • Centre Henri Becquerel
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2005
Last Updated
August 21, 2018
Sponsor
Lymphoma Study Association
Collaborators
Janssen-Cilag International NV
search

1. Study Identification

Unique Protocol Identification Number
NCT00136565
Brief Title
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2006 (Actual)
Primary Completion Date
April 18, 2011 (Actual)
Study Completion Date
April 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lymphoma Study Association
Collaborators
Janssen-Cilag International NV

4. Oversight

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
Keywords
peripheral T-cell lymphomas, bortezomib, ACVBP regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
Intervention Type
Drug
Intervention Name(s)
Velcade
Intervention Description
1.5 mg/m², D1, D5, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
75 mg/m², D1, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
60 mg/m², D1-D5, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
1200 mg/m², D1, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Description
2 mg/m², D1, D5, 4 cycles
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Description
10 mg, D1, D5, 4 cycles
Primary Outcome Measure Information:
Title
Event-free survival (EFS)
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complete response rate unconfirmed (CR+CR uncertain)
Description
percentage of patients with complete response
Time Frame
2 years
Title
Partial response (PR) rate
Description
percentage of patients with partial response
Time Frame
2 years
Title
Progression free survival (PFS)
Description
Duration of survival without progression
Time Frame
2 years
Title
Duration of response in complete responders (CR + CRu)
Time Frame
2 years
Title
Overall survival (OS)
Description
Percentage of patients alive
Time Frame
2 years
Title
Number of SAE
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Coiffier, MD
Organizational Affiliation
Hospices Civils de Lyon, Lyon, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alain Delmer, MD
Organizational Affiliation
Centre Hospitalier Robert Debré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe d'Etude des Lymphomes de l'Adulte
City
Yvoir
Country
Belgium
Facility Name
Service d'Hématologie - Centre Hospitalier Lyon-Sud
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15613697
Citation
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.
Results Reference
background
PubMed Identifier
15613699
Citation
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.
Results Reference
background
PubMed Identifier
15917644
Citation
Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.
Results Reference
background
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)

Learn more about this trial

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

We'll reach out to this number within 24 hrs