Non Hodgkin's Follicular LymphomaPhase 2NCT01830465
VELCADE® Plus Rituximab in Non Hodgkin's Follicular Lymphoma
A Phase 2 study testing Bortezomib (VELCADE) and Rituximab in people with Non Hodgkin's Follicular Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non Hodgkin's Follicular Lymphoma
- What is being tested?
- Bortezomib (VELCADE) and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2006to May 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- diagnosis of relapsed or progressed disease pretreated with no more than three prior chemotherapy regimen and/or immunochemotherapy;
- age > 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- no evidence of transformation to a high grade lymphoma;
- active disease requiring treatment;
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- two-dimensionally measurable disease in at least one site or evaluable disease;
- Velcade® naïve;
- life expectancy >6 months;
- no prior chemotherapy, immunotherapy or radiotherapy in the last 8 weeks;
- adequate renal function (calculated or measured creatinine clearance > 30 mL/minute), liver function aspartate aminotransferase (ASAT)/alanine aminotransferase (ALAT) < 3.0 x upper normal, total bilirubin < 2,5 x upper normal), unless due to lymphoma involvement;
- left ventricular ejection fraction (LVEF) > 50%;
- no evidence of active opportunistic infections;
- HbsAg, and hepatitis C virus (HCV) e HIV negativity. Positive serology for hepatitis B virus (HBV) and HCV admitted only upon negativity of HBV-DNA and HCV-RNA tests;
- no serious medical illness likely to interfere with participation in this clinically study;
- voluntary Written Informed Consent before performance of any study-related procedures;
- patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in validated translations. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible; 17. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study;
Who cannot join
- prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non melanomatous skin cancer;
- refractory disease (non responding patient to previous treatment);
- other investigational drug within 28 days before enrollment;
- evidence of symptomatic central nervous system (CNS) disease;
- severe impairment of bone marrow function (Absolute Neutrophil Count (ANC) < 1.5 x 109/L, platelet (PLT) < 50 x109/L within 14 days before enrollment), unless due to lymphoma involvement;
- evidence of ≥ grade 2 neuropathy within 14 days before enrollment;
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- known hypersensitivity to bortezomib, boron or mannitol;
- known hypersensitivity or anaphylactic reactions to murine antibodies or proteins;
- uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 7, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis;
- pregnant or lactating status, confirmation that the subject is no pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post menopausal or surgically sterilized women;
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma
The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.
Read the detailed description
Eligible patients will receive the combination Velcade-rituximab for up to a total of 6 cycles of Velcade and 6 infusion of rituximab.
Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during study treatment, at the end of the treatment and during follow up (every 6 months for 3 years). In the first stage, 17 patients will be treated. An interim analysis will be performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to determine preliminary the activity of the treatment.If > 7 responses are observed, the accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21 respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is judged promising for further development.
- Conditions
- Non Hodgkin's Follicular Lymphoma
- Being tested
- Bortezomib (VELCADE), Rituximab
- Keywords
- Non Hodgkin's Follicular Lymphoma, relapsed, progressed
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib (VELCADE)Drug
Also called VELCADE
1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6.
RituximabDrug
Also called Mabthera
375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + Rituximab | Experimental | Single arm. Patients will be treated with Bortezomib, 1,3 mg/m2 intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of 21 day cycle for 6 cycles and Rituximab 375 mg/m2 intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI. Receives: Drug: Bortezomib (VELCADE); Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity after complete treatment
Evaluate the antitumor activity in terms of clinical and molecular Overall Response Rate (ORR) after 6 courses of Velcade + Rituximab followed by two additional doses of Rituximab alone
Measured: 30 days after the last infusion of rituximab
Secondary outcomes (2)
Number of patients with adverse events
Evaluate the safety on the basis of recorded toxicities graded on a scale of 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Measured: From start of treatment until the end of follow up period (three years)
Antitumor activity after 2 cycles of Velcade alone
Early evaluate the antitumor activity in terms of clinical and molecular ORR after the first two cycles of therapy with Velcade® alone
Measured: between 1 and 2 weeks after the end of cycle II of Velcade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startAug 2006
- Primary completionAug 2008
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Sacchi, MD, Principal investigator, Gruppo Italiano Studio Linfomi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830465
- Sponsor's protocol ID
- FOLLREC3
- Status last verified
- Apr 2013
- First submitted
- 28 Dec 2010
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT01830465
- Acronym / sponsor ID
- FOLLREC3
- Conditions
- Non Hodgkin's Follicular Lymphoma
- Keywords
- Non Hodgkin's Follicular Lymphoma, relapsed, progressed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Apr 2013 (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 aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.
Detailed description
Eligible patients will receive the combination Velcade-rituximab for up to a total of 6 cycles of Velcade and 6 infusion of rituximab.
Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during study treatment, at the end of the treatment and during follow up (every 6 months for 3 years). In the first stage, 17 patients will be treated. An interim analysis will be performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to determine preliminary the activity of the treatment.If > 7 responses are observed, the accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21 respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is judged promising for further development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib + Rituximab | Experimental | Drug: Bortezomib (VELCADE), Drug: RituximabSingle arm. Patients will be treated with Bortezomib, 1,3 mg/m2 intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of 21 day cycle for 6 cycles and Rituximab 375 mg/m2 intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- diagnosis of relapsed or progressed disease pretreated with no more than three prior chemotherapy regimen and/or immunochemotherapy;
- age > 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- no evidence of transformation to a high grade lymphoma;
Key exclusion criteria (11 listed)
- prior diagnosis of neoplasm (except than follicular lymphoma) within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non melanomatous skin cancer;
- refractory disease (non responding patient to previous treatment);
- other investigational drug within 28 days before enrollment;
- evidence of symptomatic central nervous system (CNS) disease;
- severe impairment of bone marrow function (Absolute Neutrophil Count (ANC) < 1.5 x 109/L, platelet (PLT) < 50 x109/L within 14 days before enrollment), unless due to lymphoma involvement;
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 |
|---|---|---|
| Bortezomib (VELCADE)Also: VELCADE1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6. | Drug | Bortezomib + Rituximab |
| RituximabAlso: Mabthera375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI. | Drug | Bortezomib + Rituximab |
Primary outcome
Antitumor activity after complete treatment
Time frame: 30 days after the last infusion of rituximab
Evaluate the antitumor activity in terms of clinical and molecular Overall Response Rate (ORR) after 6 courses of Velcade + Rituximab followed by two additional doses of Rituximab alone
2 secondary outcomes
Number of patients with adverse events
Time frame: From start of treatment until the end of follow up period (three years)
Antitumor activity after 2 cycles of Velcade alone
Time frame: between 1 and 2 weeks after the end of cycle II of Velcade
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 12 Apr 2013.
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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.
Stefano Sacchi, MD principal investigator
Gruppo Italiano Studio Linfomi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib (VELCADE) and Rituximab in people with Non Hodgkin's Follicular Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 17 inclusion and 11 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 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Antitumor activity after complete treatment (time frame: 30 days after the last infusion of rituximab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2013.