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

Sponsor

Lymphoma Study Association (Other)

Overall Status

Completed

CT.gov ID

NCT00136565

Collaborator

Janssen-Cilag International NV (Industry)

Enrollment

Locations

Arm

63.3

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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 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

Study Type:

Interventional

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 :

Jan 8, 2006

Actual Primary Completion Date :

Apr 18, 2011

Actual Study Completion Date :

Apr 18, 2011

Arms and Interventions

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

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

Primary Outcome Measures

Event-free survival (EFS) [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

Complete response rate unconfirmed (CR+CR uncertain) [2 years]
percentage of patients with complete response
Partial response (PR) rate [2 years]
percentage of patients with partial response
Progression free survival (PFS) [2 years]
Duration of survival without progression
Duration of response in complete responders (CR + CRu) [2 years]
Overall survival (OS) [2 years]
Percentage of patients alive
Number of SAE [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Groupe d'Etude des Lymphomes de l'Adulte	Yvoir	Belgium
2	Service d'Hématologie - Centre Hospitalier Lyon-Sud	Pierre-Bénite cedex	France	69495
3	Centre Hospitalier Robert Debré	Reims	France	51092
4	Centre Henri Becquerel	Rouen	France	76038
5	Institut Gustave Roussy	Villejuif	France