Follicular LymphomaPhase 2NCT00136591
A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
A Phase 2 study testing Bortezomib in people with Follicular Lymphoma, run by Lymphoma Study Association at 4 sites in 2 countries.
Trial summary
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2005to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject 18 years or older.
- Initial diagnosis of follicular B-cell lymphoma (CD20+) (grades 1, 2, and 3 based on the World Health Organization 1997 classification), in first or subsequent relapse or progression after prior anti-neoplastic treatment including previous rituximab treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions.
- At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation.
- No active central nervous system (CNS) lymphoma
- Karnofsky Performance Status (KPS) >50% (Eastern Cooperative Oncology Group [ECOG] 0-2)
- The following laboratory values at screening, unless abnormalities are related to the lymphoma:
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- Absolute neutrophil count (ANC) >1000 cells/dL;
- Platelets >50,000 cells/dL;
- Aspartate transaminase (AST) <3 x upper limit of normal (ULN);
- Alanine transaminase (ALT) <3 x ULN;
- Total bilirubin <2 x ULN;
- Creatinine level <150 µmol/L
- Toxic effects of previous therapy or surgery resolved to Grade 2 or better.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Women are neither breast feeding nor pregnant for the duration of the study. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Male subject agrees to use an acceptable method of contraception for the duration of the study.
- Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care.
- Patient with minimum life expectancy of 3 months.
Who cannot join
- Any other type of lymphoma.
- Previous treatment with Velcade™.
- Anti-neoplastic or experimental or radiation therapy within 3 weeks before Day 1 of Cycle 1.
- Major surgery within 2 weeks before Day 1 of Cycle 1.
- Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 10 weeks before Day 1 of Cycle 1.
- Nitrosoureas within 6 weeks before Day 1 of Cycle 1.
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- Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 10 weeks before Day 1 of Cycle 1.
- Peripheral neuropathy or neuropathic pain of Grade 3 or worse.
- History of allergic reaction attributable to compounds containing boron or mannitol.
- Diagnosed or treated for a malignancy other than non-Hodgkin's lymphoma (NHL) within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy.
- Active systemic infection requiring treatment.
- Previously known HIV positive serology.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Concurrent treatment with another investigational agent.
- Adult patient under guardian.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Henri Becquerel
Rouen, 76038
Institut Gustave Roussy
Villejuif
About this study
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.
Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.
Read the detailed description
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates therapy of Velcade™ in subjects who have relapsed or refractory follicular B-cell lymphoma (FLL).
Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.
It is anticipated that approximatively 120 subjects will be enrolled to achieve the required 110 evaluable subjects, 55 in each treatment arm. Patients who receive any amount of Velcade™ are evaluable. Subjects not evaluable for response will be replaced.
A central randomization will be used in this study. Subjects will be randomized and stratified with factors for prior therapies (1 or 2 versus > 2) and time to progression (TPP) for the last given anti-neoplastic therapy (≤ 12 months versus > 12 months).
The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a 1:1 ratio:
- Subjects randomized to Treatment Arm A will receive 1.5 mg/m² Velcade™ administered biweekly on Days 1, 4, 8, and 11 of a 21-day cycle. Patients will receive 8 cycles. The dose of Velcade™ received in schedule A will be 48 mg/m² over 24 weeks.
- Subjects randomized to Treatment Arm B will receive 1.6 mg/m² Velcade™ administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle. Patients will receive 6 cycles. The dose of Velcade™ received in schedule B will be 38.4 mg/m² over 30 weeks.
Two additional cycles may be administered if the patient shows improvement to PR after 8 or 6 cycles for arm A or B, respectively.
Study drug dose and schedule reduction for toxicity will be allowed during the study.
A two stage interim analysis will be conducted in each treatment arm to determine whether either of the 2 treatments lacks sufficient efficacy.
The final analysis will be conducted when all subjects have had the opportunity to complete the 30 day post-treatment evaluation visit. All data from all visits up until this point will be used in the final analysis, including data from any follow-up visits that have occurred.
Patients will be recruited approximately over 2 years and followed until all data are available for final analysis.
The total duration of the study is expected to be 5 years.
- Conditions
- Follicular Lymphoma
- Being tested
- Bortezomib
- Keywords
- follicular lymphoma, bortezomib, relapse
- Medical subject headings
- Lymphoma, Follicular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle
BortezomibDrug
Arm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle. Subjects in this treatment arm will receive a total of 8 cycles of treatment, Receives: Drug: Bortezomib |
| B | Experimental | Not described Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate to Velcade™ as a single agent
Measured: End of treatment
Secondary outcomes (7)
To determine the overall complete response (CR) rate (CR + complete response unconfirmed [CRu])
Measured: End of treatment
To determine time to progression (TTP)
Measured: End of study
To determine overall survival
Measured: End of study
To determine duration of response
Measured: End of study
To determine the time to best response
Measured: End of study
To evaluate the safety and tolerability of Velcade™
Measured: End of study
To evaluate the effects of Velcade™ given biweekly at 1.5 mg/m2 versus 1.6 mg/m2 weekly
Measured: End of study
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 startSep 2005
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: An arm closed due to lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Follicular 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag International NV
- Investigators
- Bertrand Coiffier, MD, Study chair, Hospices Civils de Lyon, Lyon, FranceVincent Ribrag, MD, Principal investigator, Institut Gustave Roussy, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136591
- Sponsor's protocol ID
- FL05-1
- Other IDs
- Janssen: 28866138-LYM-2003, Eudrac: 2005-000734-21
- Status last verified
- Oct 2010
- First submitted
- 26 Aug 2005
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15613699Goy 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 15613697
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00136591
- Acronym / sponsor ID
- FL05-1
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma, bortezomib, relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An arm closed due to lack of efficacy
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Janssen-Cilag International NV
- Study start
- Sep 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (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.
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.
Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.
Detailed description
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates therapy of Velcade™ in subjects who have relapsed or refractory follicular B-cell lymphoma (FLL).
Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.
It is anticipated that approximatively 120 subjects will be enrolled to achieve the required 110 evaluable subjects, 55 in each treatment arm. Patients who receive any amount of Velcade™ are evaluable. Subjects not evaluable for response will be replaced.
A central randomization will be used in this study. Subjects will be randomized and stratified with factors for prior therapies (1 or 2 versus > 2) and time to progression (TPP) for the last given anti-neoplastic therapy (≤ 12 months versus > 12 months).
The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a 1:1 ratio:
- Subjects randomized to Treatment Arm A will receive 1.5 mg/m² Velcade™ administered biweekly on Days 1, 4, 8, and 11 of a 21-day cycle. Patients will receive 8 cycles. The dose of Velcade™ received in schedule A will be 48 mg/m² over 24 weeks.
- Subjects randomized to Treatment Arm B will receive 1.6 mg/m² Velcade™ administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle. Patients will receive 6 cycles. The dose of Velcade™ received in schedule B will be 38.4 mg/m² over 30 weeks.
Two additional cycles may be administered if the patient shows improvement to PR after 8 or 6 cycles for arm A or B, respectively.
Study drug dose and schedule reduction for toxicity will be allowed during the study.
A two stage interim analysis will be conducted in each treatment arm to determine whether either of the 2 treatments lacks sufficient efficacy.
The final analysis will be conducted when all subjects have had the opportunity to complete the 30 day post-treatment evaluation visit. All data from all visits up until this point will be used in the final analysis, including data from any follow-up visits that have occurred.
Patients will be recruited approximately over 2 years and followed until all data are available for final analysis.
The total duration of the study is expected to be 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: BortezomibArm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle. Subjects in this treatment arm will receive a total of 8 cycles of treatment, |
| B | Experimental | Drug: Bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subject 18 years or older.
- Initial diagnosis of follicular B-cell lymphoma (CD20+) (grades 1, 2, and 3 based on the World Health Organization 1997 classification), in first or subsequent relapse or progression after prior anti-neoplastic treatment including previous rituximab treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions.
- At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation.
- No active central nervous system (CNS) lymphoma
- Karnofsky Performance Status (KPS) >50% (Eastern Cooperative Oncology Group [ECOG] 0-2)
Key exclusion criteria (15 listed)
- Any other type of lymphoma.
- Previous treatment with Velcade™.
- Anti-neoplastic or experimental or radiation therapy within 3 weeks before Day 1 of Cycle 1.
- Major surgery within 2 weeks before Day 1 of Cycle 1.
- Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 10 weeks before Day 1 of Cycle 1.
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 |
|---|---|---|
| BortezomibArm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle | Drug | A |
| BortezomibArm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks. | Drug | B |
Primary outcome
To determine the response rate to Velcade™ as a single agent
Time frame: End of treatment
7 secondary outcomes
To determine the overall complete response (CR) rate (CR + complete response unconfirmed [CRu])
Time frame: End of treatment
To determine time to progression (TTP)
Time frame: End of study
To determine overall survival
Time frame: End of study
To determine duration of response
Time frame: End of study
To determine the time to best response
Time frame: End of study
To evaluate the safety and tolerability of Velcade™
Time frame: End of study
To evaluate the effects of Velcade™ given biweekly at 1.5 mg/m2 versus 1.6 mg/m2 weekly
Time frame: End of study
Results and safety
The study was stopped early (reason given: An arm closed due to lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- 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 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.
- 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
Vincent Ribrag, MD principal investigator
Institut Gustave Roussy, Villejuif, France
4 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 Bortezomib in people with Follicular Lymphoma, run by Lymphoma Study Association at 4 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 16 inclusion and 15 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: stopped early, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: An arm closed due to lack of efficacy). Results are not available in the source record.
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?
To determine the response rate to Velcade™ as a single agent (time frame: End of treatment). 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 NCT00136591, which also lists 2 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 26 Oct 2010.