LymphomaPhase 2NCT00662948
ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
A Phase 2 study testing Rituximab and Ibritumomab tiuxetan in people with Lymphoma, run by PETHEMA Foundation at 21 sites in Spain.
Trial summary
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to: A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Rituximab and Ibritumomab tiuxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 21 sitesSpain
- Study dates
- Dec 2008to 30 Oct 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
- Patients no treated previously.
- Ann Arbor Stage II, III o IV.
- Symptoms or signes wich indicate necesary treatment (GELF criteria):
- Ganglionar or extraganglionar mass
- B Symptoms
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- LDH or B2-microglobuline increased
- 3 ganglionar territory afected (> 3 cm)
- Esplenomegalia
- Compresive syndrome
- Pleural/peritoneal effusion
- Secondary medular insufiency due to infiltration
- Age> 18 years and <75 years.
- ECOG < 2
- Adecuate hematological function: Hemoglobin > 8,0 g/dl (5,0 mmol/L); RAN >1,5 x 109/L; platelets > 100 x 109/L
- No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
- Informed consent
Who cannot join
- Transformation in high grade lymphoma
- FL grade 3b.
- Skin or gastro-intestinal primary lymphoma
- History of CNS diseases ( or CNS lymphoma)
- Previous treatment
- Regulary treatment with corticosteroids (permited < 20 mg/day prednisone or equivalent).
Show all 17Show fewer
- Previous cancer diseases
- Major surgery in 28 days before inclusion in study.
- Creatinine > 2,0 mg/dl (197 mmol/L)
- Bilirubin > 2,0 mg/dl (34 mmol/L), AST (SGOT) > 3 x upper normal limit.
- HIV infection or active infection VHB o VHC < 4 weeks before inclusion.
- Other complicated diseases
- Criteria investigador:
- Life expectancy < 6 months.
- Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
- Treatment in other experimental study in previous 30 days
- Any medical o psicologycal condition that can modify the capacity to give the consent
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Hospital Juan Canalejo
A Coruña
Hospital de Alcorcón
Alcorcón
Hospital germans Trias i Pujol
Badalona
Hospital Clínic
Barcelona
Hospital de la santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Doce de Octubre
Madrid
Hospital La Paz
Madrid
Hospital Ramón y Cajal
Madrid
MD Anderson
Madrid
Hospital Virgen de la Arrixaca
Murcia
Hospital son Dureta
Palma de Mallorca
Hospital Clínico
Salamanca
Hospital de Donostia
San Sebastián
Hoaspital Marqués de Valdecilla
Santander
Hospital Clínico Universitario
Santiago de Compostela
Hospital Clínico
Valencia
Hospital Dr Pesset
Valencia
Hospital General
Valencia
Hospital La Fe
Valencia
About this study
Official title: Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Read the detailed description
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.
The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375 mg/m2 every 8 weeks during 24 months
Ibritumomab tiuxetanDrug
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg Receives: Drug: Ibritumomab tiuxetan |
| B | Active comparator | Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 2 years
Secondary outcomes (5)
Saffetty of two arms
Measured: 2 years
Quality of life
Measured: 7 years
Global survival
Measured: 7 years
Event free survival
Measured: 7 years
Response rate in two arms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2014
- Study completion30 Oct 2017
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 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
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Responsible party
- Sponsor
- Investigators
- Canales Miguel, Dr, Study chair, Hospital La PazLopez-Guillermo Armando, Dr, Study chair, Hospital Clinic of BarcelonaTomas Jose Francisco, Dr, Study chair, MD Anderson- Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662948
- Sponsor's protocol ID
- ZAR2007
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2008
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lopez-Guillermo A, Canales MA, Dlouhy I, Mercadal S, Briones J, Martin Garcia-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez MT, Soler A, Garcia Marco JA, Deben G, Marin J, Tomas JF; PETHEMA/GELTAMO/GELCAB Spanish Intergroup. A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results. Leuk Lymphoma. 2022 Jan;63(1):93-100. doi: 10.1080/10428194.2021.1971216. Epub 2021 Aug 30.
PubMed 34459702
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
- ClinicalTrials.gov ID
- NCT00662948
- Acronym / sponsor ID
- ZAR2007
- Conditions
- Lymphoma
- Keywords
- Folicular Lymphoma, Consolidation, Maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Collaborators
- GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Study start
- Dec 2008 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 21 Apr 2008 (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.
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Detailed description
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.
The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ibritumomab tiuxetanConsolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg |
| B | Active comparator | Drug: RituximabMaintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
- Patients no treated previously.
- Ann Arbor Stage II, III o IV.
- Symptoms or signes wich indicate necesary treatment (GELF criteria):
- Age> 18 years and <75 years.
Key exclusion criteria (17 listed)
- Transformation in high grade lymphoma
- FL grade 3b.
- Skin or gastro-intestinal primary lymphoma
- History of CNS diseases ( or CNS lymphoma)
- Previous treatment
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 |
|---|---|---|
| Rituximab375 mg/m2 every 8 weeks during 24 months | Drug | B |
| Ibritumomab tiuxetanOne dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg | Drug | A |
Primary outcome
Progression free survival
Time frame: 2 years
5 secondary outcomes
Saffetty of two arms
Time frame: 2 years
Quality of life
Time frame: 7 years
Global survival
Time frame: 7 years
Event free survival
Time frame: 7 years
Response rate in two arms
Time frame: 3 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 28 Apr 2020.
- Derived from this study: PubMed 34459702Lopez-Guillermo A, Canales MA, Dlouhy I, Mercadal S, Briones J, Martin Garcia-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez MT, Soler A, Garcia Marco JA, Deben G, Marin J, Tomas JF; PETHEMA/GELTAMO/GELCAB Spanish Intergroup. A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results. Leuk Lymphoma. 2022 Jan;63(1):93-100. doi: 10.1080/10428194.2021.1971216. Epub 2021 Aug 30.
- spanish hematology associationLink 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.
Canales Miguel, Dr study chair
Hospital La Paz
Lopez-Guillermo Armando, Dr study chair
Hospital Clinic of Barcelona
Tomas Jose Francisco, Dr study chair
MD Anderson- Madrid
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab and Ibritumomab tiuxetan in people with Lymphoma, run by PETHEMA Foundation at 21 sites in Spain.
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 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. 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?
Progression free survival (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 NCT00662948, 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 28 Apr 2020.