Mantle Cell LymphomaPhase 3NCT00921414
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
A Phase 3 study testing Rituximab and Watch and wait in people with Mantle Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Rituximab and Watch and wait
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Feb 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mantle cell lymphoma
- Initial immunophenotyping with CD20 and CD5.
- CD20+.
- t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
- Patient no previous treated.
- At least one tumor site accessible for assessment
Show all 11Show fewer
- Aged > 18 years < 65
- ECOG < or = 2.
- No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
- signed informed consent
- FEVG 50%
Who cannot join
- other type of lymphoma
- ECOG > or = 3
- relapse
- serology VIH + Hepatite +
- diabetis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
Read the detailed description
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Rituximab, Watch and wait
- Keywords
- Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera®
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Watch and waitOther
Also called observation
No treatment patient follow-up every 2 months during 3 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | observation : 3 years maintenance period with assesments and surveillance every 2 months Receives: Other: Watch and wait |
| 2 | Experimental | maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival (EFS) post Rituximab maintenance therapy
Measured: EFS post 4 years after maintenance
Secondary outcomes (3)
duration of PFS of the entire group of patients.
Measured: Safety/efficacy of maintenance treatment
duration of OS of the entire group of patients
Measured: safety/efficacy of treatment
complete, partial and overall response rate after induction with R-DHAP and after ASCT.
Measured: safety/efficacy of all the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionFeb 2017
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 Mantle Cell 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
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Lymphoma Study Association
- Responsible party
- Sponsor
- Investigators
- Steven LE GOUILL, MD, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921414
- Sponsor's protocol ID
- Manteau 2007 SJ "LYMA"
- Status last verified
- Apr 2018
- First submitted
- 27 May 2009
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.
PubMed 38669626Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.
PubMed 28953447
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
- ClinicalTrials.gov ID
- NCT00921414
- Acronym / sponsor ID
- Manteau 2007 SJ "LYMA"
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Mantle cell lymphoma, R DHAP, ASCT, Rituximab Maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Lymphoma Study Association
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Jun 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.
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
Detailed description
Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Watch and waitobservation : 3 years maintenance period with assesments and surveillance every 2 months |
| 2 | Experimental | Drug: Rituximabmaintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- mantle cell lymphoma
- Initial immunophenotyping with CD20 and CD5.
- CD20+.
- t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
- Patient no previous treated.
Key exclusion criteria (5 listed)
- other type of lymphoma
- ECOG > or = 3
- relapse
- serology VIH + Hepatite +
- diabetis
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 |
|---|---|---|
| RituximabAlso: Mabthera®2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years | Drug | 2 |
| Watch and waitAlso: observationNo treatment patient follow-up every 2 months during 3 years | Other | 1 |
Primary outcome
event-free survival (EFS) post Rituximab maintenance therapy
Time frame: EFS post 4 years after maintenance
3 secondary outcomes
duration of PFS of the entire group of patients.
Time frame: Safety/efficacy of maintenance treatment
duration of OS of the entire group of patients
Time frame: safety/efficacy of treatment
complete, partial and overall response rate after induction with R-DHAP and after ASCT.
Time frame: safety/efficacy of all the treatment
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 27 Apr 2018.
- Derived from this study: PubMed 38669626Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.
- Derived from this study: PubMed 28953447Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.
- FILO WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Steven LE GOUILL, MD principal investigator
French Innovative Leukemia Organisation
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 Rituximab and Watch and wait in people with Mantle Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
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 11 inclusion and 5 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 27 Apr 2018. 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 France. 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?
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?
event-free survival (EFS) post Rituximab maintenance therapy (time frame: EFS post 4 years after maintenance). 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 NCT00921414, 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 27 Apr 2018.