Follicular LymphomaPhase 3NCT00435955
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma
A Phase 3 study testing High dose chemotherapy with autologous transplantation and Rituximab in people with Follicular Lymphoma, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- High dose chemotherapy with autologous transplantation and Rituximab
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2000to not given
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Follicular Lymphoma at diagnosis
- Stage >I
- age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score
Who cannot join
- Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
- Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
- Evidence of second tumors;
- Previous chemotherapy( except patients who received limited radiotherapy);
- Cerebral or CNS involvement.
- Drug addiction or severe psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA
The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.
Read the detailed description
The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab age. According to these studies, ASCT improved overall survival versus standard salvage approaches in relapsed patients with a high proportion of patients achieving a durable molecular remission. Data at diagnosis are less clear. Three studies have been so far published with contradictory results. Two of these studies showed that intensive therapy ensures a better disease control although in one study a significant extra-mortality from secondary tumors was observed in the intensified arm. A third study found no advantage for patients treated intensively. These results led to the widespread notion that ASCT is not superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some clues to these considerations. Our study employs an autografting procedure which is associated to fewer secondary tumors as it does not include total body irradiation. Moreover we have observed that the our regimen (named HDS) is particularly effective in high-risk patients, suggesting that this specific subgroup is the most appropriate setting for intensified regimens
The present multicenter open label randomized trial took advantage of these observations. In addition we have included Rituximab in both arms as the inclusion of this novel agent is expected to significantly modify the performance of available treatments. We have thus compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses supplemented by an identical number of Rituximab courses. Aim of the study was verify if an intensified approach could be beneficial as first line treatment of high-risk FL patients in the Rituximab age.
- Conditions
- Follicular Lymphoma
- Being tested
- High dose chemotherapy with autologous transplantation, Rituximab
- Keywords
- Follicular lymphoma, age adjusted IPI >1, IIL score > 2, Molecular remission, High dose chemotherapy and autologous transplantation, Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose chemotherapy with autologous transplantationProcedure or surgery
RituximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival at three years
Secondary outcomes (7)
Overall survival
CR rate
Progression free survival
Disease free survival I
Incidence of secondary myelodisplasia and solid cancer
Rate of molecular remission
Predictive value of molecular remission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startMar 2000
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy, Gruppo Italiano Trapianto di Midollo Osseo, Gruppo Italiano Studio Linfomi, Hoffmann-La Roche
- Investigators
- Corrado Tarella, MD, Principal investigator, Università di Torino, Azienda Ospedaliera San Giovanni BattistaMarco Ladetto, MD, Principal investigator, Università di Torino Azienda Ospedaliera San Giovanni BattistaAlessandro Pileri, MD, Principal investigator, Università di Torino Azienda Ospedaliera San Giovanni Battista (Now retired)Mario Boccadoro, Principal investigator, Università di Torino/Azienda Ospedaliera San Giovanni Battista BAlessandro Gianni, Principal investigator, Istituto Tumori di Milano, Milano Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435955
- Sponsor's protocol ID
- 3320
- Status last verified
- Feb 2007
- First submitted
- 15 Feb 2007
- Last updated
- 16 Feb 2007
- Results posted
- No
Publications
Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.
PubMed 18239086
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTICENTER RANDOMIZED PROGRAM COMPARING HIGH-DOSE CHEMOTHERAPY + RITUXIMAB AND PERIPHERAL BLOOD PROGENITOR CELL (PBPC) AUTOGRAFT vs. CHOP + RITUXIMAB AS FIRST-LINE TREATMENT FOR PATIENTS WITH HIGH-RISK FOLLICULAR LYMPHOMA
- ClinicalTrials.gov ID
- NCT00435955
- Acronym / sponsor ID
- 3320
- Conditions
- Follicular Lymphoma
- Keywords
- Follicular lymphoma, age adjusted IPI >1, IIL score > 2, Molecular remission, High dose chemotherapy and autologous transplantation, Rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Collaborators
- University of Turin, Italy, Gruppo Italiano Trapianto di Midollo Osseo, Gruppo Italiano Studio Linfomi, Hoffmann-La Roche
- Study start
- Mar 2000
- First posted
- 16 Feb 2007 (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 whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.
Detailed description
The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab age. According to these studies, ASCT improved overall survival versus standard salvage approaches in relapsed patients with a high proportion of patients achieving a durable molecular remission. Data at diagnosis are less clear. Three studies have been so far published with contradictory results. Two of these studies showed that intensive therapy ensures a better disease control although in one study a significant extra-mortality from secondary tumors was observed in the intensified arm. A third study found no advantage for patients treated intensively. These results led to the widespread notion that ASCT is not superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some clues to these considerations. Our study employs an autografting procedure which is associated to fewer secondary tumors as it does not include total body irradiation. Moreover we have observed that the our regimen (named HDS) is particularly effective in high-risk patients, suggesting that this specific subgroup is the most appropriate setting for intensified regimens
The present multicenter open label randomized trial took advantage of these observations. In addition we have included Rituximab in both arms as the inclusion of this novel agent is expected to significantly modify the performance of available treatments. We have thus compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses supplemented by an identical number of Rituximab courses. Aim of the study was verify if an intensified approach could be beneficial as first line treatment of high-risk FL patients in the Rituximab age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Follicular Lymphoma at diagnosis
- Stage >I
- age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score
Key exclusion criteria (6 listed)
- Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
- Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
- Evidence of second tumors;
- Previous chemotherapy( except patients who received limited radiotherapy);
- Cerebral or CNS 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 |
|---|---|---|
| High dose chemotherapy with autologous transplantation | Procedure or surgery | – |
| Rituximab | Drug | – |
Primary outcome
Event free survival at three years
7 secondary outcomes
Overall survival
CR rate
Progression free survival
Disease free survival I
Incidence of secondary myelodisplasia and solid cancer
Rate of molecular remission
Predictive value of molecular remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2007.
- Derived from this study: PubMed 18239086Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.
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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.
Corrado Tarella, MD principal investigator
Università di Torino, Azienda Ospedaliera San Giovanni Battista
Marco Ladetto, MD principal investigator
Università di Torino Azienda Ospedaliera San Giovanni Battista
Alessandro Pileri, MD principal investigator
Università di Torino Azienda Ospedaliera San Giovanni Battista (Now retired)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High dose chemotherapy with autologous transplantation and Rituximab in people with Follicular Lymphoma, run by Azienda Ospedaliera San Giovanni Battista 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Feb 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Event free survival at three 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 NCT00435955, 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 16 Feb 2007.