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

Peripheral T-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136565
• Other study ID #: LNH05-1T
• Secondary ID: Janssen: i061-34
• Status: Completed
• Phase: Phase 2
• Start date: January 8, 2006
• Est. completion date: April 18, 2011

Study information

• Verified date: August 2018
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 18, 2011
• Est. primary completion date: April 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Velcade
1.5 mg/m², D1, D5, 4 cycles
• Doxorubicin
75 mg/m², D1, 4 cycles
• Prednisone
60 mg/m², D1-D5, 4 cycles
• Cyclophosphamide
1200 mg/m², D1, 4 cycles
• Vindesine
2 mg/m², D1, D5, 4 cycles
• Bleomycin
10 mg, D1, D5, 4 cycles

Locations

Country	Name	City	State
Belgium	Groupe d'Etude des Lymphomes de l'Adulte	Yvoir
France	Service d'Hématologie - Centre Hospitalier Lyon-Sud	Pierre-Bénite cedex
France	Centre Hospitalier Robert Debré	Reims
France	Centre Henri Becquerel	Rouen
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Lymphoma Study Association	Janssen-Cilag International NV

Countries where clinical trial is conducted

Belgium,  France, 

References & 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. Epub 2004 Dec 21. — View 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. Epub 2004 Dec 21. — View Citation

Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete response rate unconfirmed (CR+CR uncertain)	percentage of patients with complete response	2 years
Secondary	Partial response (PR) rate	percentage of patients with partial response	2 years
Secondary	Progression free survival (PFS)	Duration of survival without progression	2 years
Secondary	Duration of response in complete responders (CR + CRu)		2 years
Secondary	Overall survival (OS)	Percentage of patients alive	2 years
Secondary	Number of SAE		2 years

External Links

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