Follicular LymphomaPhase 2FM+R-ZNCT00859001
Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy
A Phase 2 study testing FM+R and Zevalin (Ibritumomab Tiuxetan) in people with Follicular Lymphoma, run by University of Bologna at 1 site in Italy.
Trial summary
Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. 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?
- FM+R and Zevalin (Ibritumomab Tiuxetan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- 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
- Histologically confirmed FL grade I-II according to the REAL/WHO classification (from initial diagnosis made prior to starting FMR therapy);
- FLIPI 3 or more
- Central pathology review confirming the FL grade I-II diagnosis and CD20 positivity, and no evidence/evidence with an infiltration <25% of FL in bone marrow;
- The first part of the treatment of FL must have been 4 cycles of standard FM chemotherapy (fludarabine 25 mg/m2/day on days 1 to 3 and mitoxantrone 10 mg/m2 on day 1) in combination with rituximab (375 mg/m2); Complete remission (CR), unconfirmed complete remission (CRu), partial response, and non-responder according to the International Workshop Response Criteria for NHL described by Cheson et al after four cycles of FMR. CT scans of the neck, thorax, abdomen, and pelvis and PET total body must have been performed within 3 weeks after the last dose of the last course of FMR;
- Patients 18-years-of-age or older at time of accrual;
- WHO performance status (PS) of 0 to 2 within 1 week of accrual;
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- Absolute neutrophil count (ANC) more than 1.5 x 109/L within 1 week of accrual;
- Hemoglobin (Hgb) more than10 g/dL within 1 week of accrual;
- Platelets more than 150 x 109/L within 1 week of accrual.
- Written informed consent obtained according to local guidelines
Who cannot join
- Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma;
- Prior radioimmunotherapy, radiation therapy, or any other NHL therapy;
- Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis;
- Histological transformation of low-grade NHL;
- Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg);
- Known history of HIV infection;
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- Abnormal liver function: total bilirubin > 1.5 x ULN or ALT > 2.5 x ULN within 1 week of accrual;
- Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of accrual;
- Known hypersensitivity to murine or chimeric antibodies or proteins;
- G-CSF or GM-CSF therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling;
- Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study;
- Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment;
- Female patients who are pregnant or are currently breastfeeding;
- Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy;
- Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery;
- Concurrent corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment;
- Unwillingness or inability to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto di Ematologia e Oncologia Medica Seràgnoli
Bologna, BO, 40138
About this study
Official title: A Phase II, Open-Label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy.
Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.
Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life Patient population: Patients with after 4 cycles of treatment with FMR Study design: Prospective, multicenter, open-label study designed to treat patients with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of treatment: Four months for FMR and two treatment days one week apart followed by a 12-week safety period for Zevalin Duration of study: Estimated duration of study is 18 months Primary efficacy parameter: Overall response rate and complete response rate Secondary efficacy parameters: Overall survival, Disease-free survival, health-related quality of life.
Read more
Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry,and immunoglobulin levels Number of study centers: 4 study centers in Italy T otal number of patients, statistical rationale provided: Expected total of 55 patients. The final sample size will be based on the number of events observed for the primary efficacy endpoint as calculated in the sequential statistical model.
Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported will be documented.
Planned start and end of recruitment: Start of recruitment: 3rd quarter 2006. End of recruitment: 1st quarter of 2007
- Conditions
- Follicular Lymphoma
- Being tested
- FM+R, Zevalin (Ibritumomab Tiuxetan)
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM+RDrug
Fludarabine-Mitoxantrone-Rituximab
Zevalin (Ibritumomab Tiuxetan)Drug
| Study group | Role | What they receive |
|---|---|---|
| FM+R | Experimental | 4 cycles of FM+R plus Zevalin Receives: Drug: FM+R; Drug: Zevalin (Ibritumomab Tiuxetan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (1)
disease-free survival, complete response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859001
- Sponsor's protocol ID
- FM+R-Z
- Acronym
- FM+R-Z
- Status last verified
- Mar 2009
- First submitted
- 9 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
Publications
Zinzani PL, Tani M, Pulsoni A, Gobbi M, Perotti A, De Luca S, Fabbri A, Zaccaria A, Voso MT, Fattori P, Guardigni L, Ronconi S, Cabras MG, Rigacci L, De Renzo A, Marchi E, Stefoni V, Fina M, Pellegrini C, Musuraca G, Derenzini E, Pileri S, Fanti S, Piccaluga PP, Baccarani M. Fludarabine and mitoxantrone followed by yttrium-90 ibritumomab tiuxetan in previously untreated patients with follicular non-Hodgkin lymphoma trial: a phase II non-randomised trial (FLUMIZ). Lancet Oncol. 2008 Apr;9(4):352-8. doi: 10.1016/S1470-2045(08)70039-1. Epub 2008 Mar 14.
PubMed 18342572
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study in Patients With Follicular Grade I-II Lymphoma After 4 Cycles of Fludarabine-Mitoxantrone-Rituximab (FMR) Therapy.
- ClinicalTrials.gov ID
- NCT00859001
- Acronym / sponsor ID
- FM+R-Z / FM+R-Z
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- First posted
- 10 Mar 2009 (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.
Study phase: Phase II Investigational product, dosage, and route of administration: Ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. To prepare the active therapeutic agent [90Y]-ibritumomab tiuxetan, the antibody is chelated with the β-emitter yttrium-90 chloride immediately before intravenous administration. Treatment with [90Y]-ibritumomab tiuxetan is preceded by an infusion of rituximab (Rituxan, Mabthera) in order to optimize the biodistribution of radiolabeled antibody by depleting CD20 positive B-cells. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. The Zevalin study regimen is given as an infusion of rituximab 250 mg/m2 and (where biodistribution imaging or dosimetry is compulsory) 185 MBq (5mCi) of [111In]-ibritumomab tiuxetan on Day 1 followed 7 to 9 days later by a single dose of 14.8 MBq/kg (0.4 mCi/kg) of [90Y]-ibritumomab tiuxetan, maximal dose of 1184 MBq (32 mCi), preceded by 250 mg/m2 of rituximab.
Indication: stage II-IV follicular lymphoma (FL) grade I-II after 4 cycles of FMR Study objectives: Evaluation of efficacy and safety of [90Y]-ibritumomab tiuxetan, as well as assessment of quality of life Patient population: Patients with after 4 cycles of treatment with FMR Study design: Prospective, multicenter, open-label study designed to treat patients with a sequential front-line treatment represented by 4 cycles FMR plus Zevalin Duration of treatment: Four months for FMR and two treatment days one week apart followed by a 12-week safety period for Zevalin Duration of study: Estimated duration of study is 18 months Primary efficacy parameter: Overall response rate and complete response rate Secondary efficacy parameters: Overall survival, Disease-free survival, health-related quality of life.
Safety parameters: Vital signs, adverse events (AEs), hematology, blood chemistry,and immunoglobulin levels Number of study centers: 4 study centers in Italy T otal number of patients, statistical rationale provided: Expected total of 55 patients. The final sample size will be based on the number of events observed for the primary efficacy endpoint as calculated in the sequential statistical model.
Adverse events: AEs observed, mentioned upon open questioning and/or spontaneously reported will be documented.
Planned start and end of recruitment: Start of recruitment: 3rd quarter 2006. End of recruitment: 1st quarter of 2007
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FM+R | Experimental | Drug: FM+R, Drug: Zevalin (Ibritumomab Tiuxetan)4 cycles of FM+R plus Zevalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed FL grade I-II according to the REAL/WHO classification (from initial diagnosis made prior to starting FMR therapy);
- FLIPI 3 or more
- Central pathology review confirming the FL grade I-II diagnosis and CD20 positivity, and no evidence/evidence with an infiltration <25% of FL in bone marrow;
- The first part of the treatment of FL must have been 4 cycles of standard FM chemotherapy (fludarabine 25 mg/m2/day on days 1 to 3 and mitoxantrone 10 mg/m2 on day 1) in combination with rituximab (375 mg/m2); Complete remission (CR), unconfirmed complete remission (CRu), partial response, and non-responder according to the International Workshop Response Criteria for NHL described by Cheson et al after four cycles of FMR. CT scans of the neck, thorax, abdomen, and pelvis and PET total body must have been performed within 3 weeks after the last dose of the last course of FMR;
- Patients 18-years-of-age or older at time of accrual;
Key exclusion criteria (17 listed)
- Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma;
- Prior radioimmunotherapy, radiation therapy, or any other NHL therapy;
- Presence of gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis;
- Histological transformation of low-grade NHL;
- Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg);
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 |
|---|---|---|
| FM+RFludarabine-Mitoxantrone-Rituximab | Drug | FM+R |
| Zevalin (Ibritumomab Tiuxetan) | Drug | FM+R |
Primary outcome
Overall survival
1 secondary outcome
disease-free survival, complete response
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 Mar 2009.
- Background: PubMed 18342572Zinzani PL, Tani M, Pulsoni A, Gobbi M, Perotti A, De Luca S, Fabbri A, Zaccaria A, Voso MT, Fattori P, Guardigni L, Ronconi S, Cabras MG, Rigacci L, De Renzo A, Marchi E, Stefoni V, Fina M, Pellegrini C, Musuraca G, Derenzini E, Pileri S, Fanti S, Piccaluga PP, Baccarani M. Fludarabine and mitoxantrone followed by yttrium-90 ibritumomab tiuxetan in previously untreated patients with follicular non-Hodgkin lymphoma trial: a phase II non-randomised trial (FLUMIZ). Lancet Oncol. 2008 Apr;9(4):352-8. doi: 10.1016/S1470-2045(08)70039-1. Epub 2008 Mar 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 FM+R and Zevalin (Ibritumomab Tiuxetan) in people with Follicular Lymphoma, run by University of Bologna 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 10 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 12 Mar 2009. 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?
Overall survival. 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 NCT00859001, which also lists 1 linked publication.
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 Mar 2009.