Peripheral T-cell LymphomaPhase 2NCT00136565
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
A Phase 2 study testing Velcade, Doxorubicin and Prednisone in people with Peripheral T-cell Lymphoma, run by Lymphoma Study Association at 5 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Velcade, Doxorubicin and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Jan 2006to 18 Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Hospitalier Robert Debré
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Institut Gustave Roussy
Villejuif
About this study
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
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).
Read the 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).
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Velcade, Doxorubicin, Prednisone, Cyclophosphamide, Vindesine
- Keywords
- peripheral T-cell lymphomas, bortezomib, ACVBP regimen
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelcadeDrug
1.5 mg/m², D1, D5, 4 cycles
DoxorubicinDrug
75 mg/m², D1, 4 cycles
PrednisoneDrug
60 mg/m², D1-D5, 4 cycles
CyclophosphamideDrug
1200 mg/m², D1, 4 cycles
VindesineDrug
2 mg/m², D1, D5, 4 cycles
BleomycinDrug
10 mg, D1, D5, 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Velcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone Receives: Drug: Velcade; Drug: Doxorubicin; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Vindesine; Drug: Bleomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
Complete response rate unconfirmed (CR+CR uncertain)
percentage of patients with complete response
Measured: 2 years
Partial response (PR) rate
percentage of patients with partial response
Measured: 2 years
Progression free survival (PFS)
Duration of survival without progression
Measured: 2 years
Duration of response in complete responders (CR + CRu)
Measured: 2 years
Overall survival (OS)
Percentage of patients alive
Measured: 2 years
Number of SAE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study start8 Jan 2006
- Primary completion18 Apr 2011
- Study completion18 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag International NV
- Responsible party
- Sponsor
- Investigators
- Bertrand Coiffier, MD, Study chair, Hospices Civils de Lyon, Lyon, FranceAlain Delmer, MD, Principal investigator, Centre Hospitalier Robert Debré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136565
- Sponsor's protocol ID
- LNH05-1T
- Other IDs
- Janssen: i061-341-03, Eudract: 2005-001563-66
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2005
- Last updated
- 23 Aug 2018
- Results posted
- No
Publications
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.
PubMed 15613697O'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.
PubMed 15613699Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.
PubMed 15917644
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00136565
- Acronym / sponsor ID
- LNH05-1T
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- peripheral T-cell lymphomas, bortezomib, ACVBP regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Janssen-Cilag International NV
- Study start
- 8 Jan 2006 (actual)
- Primary completion
- 18 Apr 2011 (actual)
- Study completion
- 18 Apr 2011 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Velcade, Drug: Doxorubicin, Drug: Prednisone, Drug: Cyclophosphamide, Drug: Vindesine, Drug: BleomycinVelcade, Doxorubicine, Cyclophosphamide, Vindesine, Bleomycin, Prednisone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Velcade1.5 mg/m², D1, D5, 4 cycles | Drug | Experimental |
| Doxorubicin75 mg/m², D1, 4 cycles | Drug | Experimental |
| Prednisone60 mg/m², D1-D5, 4 cycles | Drug | Experimental |
| Cyclophosphamide1200 mg/m², D1, 4 cycles | Drug | Experimental |
| Vindesine2 mg/m², D1, D5, 4 cycles | Drug | Experimental |
| Bleomycin10 mg, D1, D5, 4 cycles | Drug | Experimental |
Primary outcome
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
6 secondary outcomes
Complete response rate unconfirmed (CR+CR uncertain)
Time frame: 2 years
Partial response (PR) rate
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Duration of response in complete responders (CR + CRu)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Number of SAE
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 15613697Goy 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.
- Background: PubMed 15613699O'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.
- Background: PubMed 15917644Orlowski RZ. Proteasome inhibitors in cancer therapy. Methods Mol Biol. 2005;301:339-50. doi: 10.1385/1-59259-895-1:339.
- Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Coiffier, MD study chair
Hospices Civils de Lyon, Lyon, France
Alain Delmer, MD principal investigator
Centre Hospitalier Robert Debré
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Velcade, Doxorubicin and Prednisone in people with Peripheral T-cell Lymphoma, run by Lymphoma Study Association at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136565, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.