Lymphoma, Mantle-CellPhase 3MCLelderlyNCT00209209
Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL
A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Lymphoma, Mantle-Cell, run by European Mantle Cell Lymphoma Network at 7 sites in 7 countries.
Trial summary
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas: Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell
- What is being tested?
- Rituximab, Cyclophosphamide and Doxorubicin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 14 Jan 2004to Dec 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven mantle cell lymphoma according to the World Health Organization (WHO) classification, preferably confirmed by central pathology review before entering the study
- Clinical stage II, III or IV
- Previously untreated patients
- Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
- WHO performance grade 0, 1 or 2
- Informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/European Union Good Clinical Practice (ICH/EU GCP) and national/local regulations
- Measurable disease. If, for example only bone marrow (BM) infiltration, patients can only undergo a second randomization if a CR is obtained.
Who cannot join
- WHO performance of 3 or more
- Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- Leukocytes <2.0x 10^9/l or thrombocytes <100x 10^9/l, unless clearly related to mantle cell lymphoma (MCL) bone marrow infiltration
- Patients previously treated for lymphoma
- Patients without measurable lesions; if, for example only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of a CR
- Patients with stage I disease
Show all 17Show fewer
- Patients with central nervous system involvement
- Patients with a history of autoimmune hemolytic anaemia or autoimmune thrombocytopenia
- Patients with serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure)
- Patients with serious pulmonary, neurological, endocrinological or other disorder interfering with full dosing of CHOP or FC chemotherapy
- Liver enzymes >3x normal or bilirubin >2.5x normal (not due to lymphoma)
- Creatinine >2x normal value, corrected for age and weight (not due to lymphoma)
- Patients with unresolved hepatitis B or C infection or known HIV positive infection
- Uncontrolled infection
- Patients with a serious depression that needed therapy within the last 5 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Czechia1 site
General University Hospital, 1St Department of Medicine
Prague, CZ-12808
Netherlands1 site
HOVON - Dutch Haemato-Oncology Association (HOVON-Datacenter)
Rotterdam, NL-3008 AE
Poland1 site
The Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology
Warsaw, PL-02-781
About this study
Official title: Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:
- Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
- Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?
Read the detailed description
This study investigates two independent questions in the treatment of elderly patients with mantle cell lymphomas:
- To test in elderly patients with advanced mantle cell lymphoma, whether rituximab plus a combination of fludarabine with cyclophosphamide (6 FC cycles) results in a higher reduction of lymphoma mass measured by the percentage of CR than rituximab combined with the standard chemotherapy scheme (8 CHOP cycles).
- To compare maintenance therapy with rituximab with maintenance with interferon-alpha or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with mantle cell lymphoma.
This study will be performed as a prospective, randomized, open-label multicenter phase III trial. All patients will be randomized for an initial cytoreductive therapy with R-FC or R-CHOP.
The parameter for the comparison of R-FC and R-CHOP will be the percentage of complete remissions after initial cytoreductive therapy. According to the known results of R-FC and R-CHOP in lymphoma therapy, a relevant difference between R-CHOP and R-FC in the overall response rates is not expected. For both therapies an overall response rate of about 90% is expected. Since it is well known that the prognosis of patients who do not reach at least a PR in the initial therapy is very poor, it will be also necessary to control this parameter during the study. If an unexpected relevant difference in the overall response rates is observed during the study, the initial randomisation should be stopped and all patients should be assigned to the superior therapy. In this case the CR rates will not be important for the choice of the initial therapy. If no relevant differences in the overall response rates are observed, a one sided Fisher test will be performed at the end of the recruitment to test whether the rate of CR's after R-FC is significantly improved compared to R-CHOP.
The statistical parameters for controlling the overall response rates and for testing the CR rates are chosen in the following way: The working significance level for all statistical evaluations in this part of the study will be set to alpha=0.05. The expected CR rate after R-CHOP is according to the observations about 50%; a clinical relevant improvement by R-FC would be a CR rate of 65%. Such an improvement should be detected by the one sided Fisher test with a power of about 95%. According to these parameters about 246 observations for each treatment would be necessary. To control the overall response rates, a difference of 85% to 95% will be clinically so relevant that initial randomisation should be terminated with a probability of about 95%. Overall response rates will be controlled by a restricted sequential procedure.
Patients achieving at least a partial remission after R-FC or R-CHOP will be randomised for interferon maintenance versus rituximab maintenance in order to evaluate the impact of maintenance therapy in progression free survival.
The improvement expected by the new maintenance with rituximab for progression free survival can be expressed by reduction of relative risk (rr). Since a risk reduction to 60% was observed for indolent lymphomas by interferon maintenance, this seems to be a clinical relevant improvement for the new maintenance therapy. For a working significance level alpha=0.05 and a power of 95% the number of events (relapse or death) necessary for a two sided fixed sample trial is about 200. During this study the progression free survival in patients after successful initial therapy will be monitored by an equivalent restricted sequential procedure with a maximum number of 240 observation.
In order to evaluate the impact of initial therapy and maintenance therapy on overall survival in this patients, a total follow up of about 15 years for this study is expected.
- Conditions
- Lymphoma, Mantle-Cell
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Keywords
- Lymphoma, Mantle-Cell, Elderly patients, Chemotherapy, Maintenance therapy, C04.557.386.480.300.725.500, C15.604.515.569.480.300.725.500, C20.683.515.761.480.300.725.500
- 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
antibody
CyclophosphamideDrug
chemotherapy
DoxorubicinDrug
chemotherapy
VincristineDrug
chemotherapy
PrednisoneDrug
coricosteroide
FludarabineDrug
chemotherapy
Interferon-alphaDrug
cytokine
pegylated formula Interferon-alpha 2bDrug
cytokine
chemotherapy: R-CHOPProcedure or surgery
immuno-chemotherapy
chemotherapy: R-FCProcedure or surgery
immuno-chemotherapy
Interferon maintenanceProcedure or surgery
cytokine
Rituximab maintenanceProcedure or surgery
antibody
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1. randomisation: R-CHOP
2. randomisation: IFN maintenance Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Interferon-alpha; Drug: pegylated formula Interferon-alpha 2b; Procedure: chemotherapy: R-CHOP; Procedure: Interferon maintenance |
| 2 | Experimental | 1. randomisation: R-FC
2. randomisation: Rituximab maintnenance Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine; Procedure: chemotherapy: R-FC; Procedure: Rituximab maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate
Second randomisation: progression-free survival after end of initial chemotherapy
Secondary outcomes (6)
Survival after registration / first randomisation / second randomisation
Survival after start / end of initial therapy
Time to treatment failure after start of initial therapy
Progression free survival after registration / first randomisation / second randomisation
Side-effects of initial therapy
Side-effects of maintenance therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start14 Jan 2004
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Mantle-CellStudies 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
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Mantle Cell Lymphoma Network
- Sponsor type
- University, hospital or other
- Collaborators
- German Low Grade Lymphoma Study Group, Lymphoma Study Association, HOVON - Dutch Haemato-Oncology Association, Nordic Lymphoma Group
- Responsible party
- Principal investigator, Prof. Dr. M. Dreyling (co-chairman), European Mantle Cell Lymphoma Network
- Investigators
- Hanneke C. Kluin-Nelemans, PhD, Principal investigator, University Hospital Groningen, Dept. of HematologyMartin Dreyling, PhD, Study chair, University Hospital Grosshadern/LMU, Dept. of Medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209209
- Sponsor's protocol ID
- MCL2004-1
- Acronym
- MCLelderly
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Prochazka V, Di Raimondo F, Ribrag V, Uppenkamp M, Andre M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. doi: 10.1056/NEJMoa1200920.
PubMed 22873532Hoster E, Delfau-Larue MH, Macintyre E, Jiang L, Stilgenbauer S, Vehling-Kaiser U, Salles G, Thieblemont C, Tilly H, Wirths S, Feugier P, Hubel K, Schmidt C, Ribrag V, Kluin-Nelemans JC, Dreyling M, Pott C; European MCL MRD Working Group and the European MCL Network. Predictive Value of Minimal Residual Disease for Efficacy of Rituximab Maintenance in Mantle Cell Lymphoma: Results From the European Mantle Cell Lymphoma Elderly Trial. J Clin Oncol. 2024 Feb 10;42(5):538-549. doi: 10.1200/JCO.23.00899. Epub 2023 Nov 22.
PubMed 37992261Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Geisler CH, Trneny M, Stilgenbauer S, Kaiser F, Doorduijn JK, Salles G, Szymczyk M, Tilly H, Kanz L, Schmidt C, Feugier P, Thieblemont C, Zijlstra JM, Ribrag V, Klapper W, Pott C, Unterhalt M, Dreyling MH. Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. J Clin Oncol. 2020 Jan 20;38(3):248-256. doi: 10.1200/JCO.19.01294. Epub 2019 Dec 5.
PubMed 31804876Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.
PubMed 24687837Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.
PubMed 20032498
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00209209
- Acronym / sponsor ID
- MCLelderly / MCL2004-1
- Conditions
- Lymphoma, Mantle-Cell
- Keywords
- Lymphoma, Mantle-Cell, Elderly patients, Chemotherapy, Maintenance therapy, C04.557.386.480.300.725.500, C15.604.515.569.480.300.725.500, C20.683.515.761.480.300.725.500
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- European Mantle Cell Lymphoma NetworkUniversity, hospital or other
- Collaborators
- German Low Grade Lymphoma Study Group, Lymphoma Study Association, HOVON - Dutch Haemato-Oncology Association, Nordic Lymphoma Group
- Study start
- 14 Jan 2004 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Sep 2005 (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 is to answer the following independent questions in the treatment of mantle cell lymphomas:
- Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
- Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?
Detailed description
This study investigates two independent questions in the treatment of elderly patients with mantle cell lymphomas:
- To test in elderly patients with advanced mantle cell lymphoma, whether rituximab plus a combination of fludarabine with cyclophosphamide (6 FC cycles) results in a higher reduction of lymphoma mass measured by the percentage of CR than rituximab combined with the standard chemotherapy scheme (8 CHOP cycles).
- To compare maintenance therapy with rituximab with maintenance with interferon-alpha or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with mantle cell lymphoma.
This study will be performed as a prospective, randomized, open-label multicenter phase III trial. All patients will be randomized for an initial cytoreductive therapy with R-FC or R-CHOP.
The parameter for the comparison of R-FC and R-CHOP will be the percentage of complete remissions after initial cytoreductive therapy. According to the known results of R-FC and R-CHOP in lymphoma therapy, a relevant difference between R-CHOP and R-FC in the overall response rates is not expected. For both therapies an overall response rate of about 90% is expected. Since it is well known that the prognosis of patients who do not reach at least a PR in the initial therapy is very poor, it will be also necessary to control this parameter during the study. If an unexpected relevant difference in the overall response rates is observed during the study, the initial randomisation should be stopped and all patients should be assigned to the superior therapy. In this case the CR rates will not be important for the choice of the initial therapy. If no relevant differences in the overall response rates are observed, a one sided Fisher test will be performed at the end of the recruitment to test whether the rate of CR's after R-FC is significantly improved compared to R-CHOP.
The statistical parameters for controlling the overall response rates and for testing the CR rates are chosen in the following way: The working significance level for all statistical evaluations in this part of the study will be set to alpha=0.05. The expected CR rate after R-CHOP is according to the observations about 50%; a clinical relevant improvement by R-FC would be a CR rate of 65%. Such an improvement should be detected by the one sided Fisher test with a power of about 95%. According to these parameters about 246 observations for each treatment would be necessary. To control the overall response rates, a difference of 85% to 95% will be clinically so relevant that initial randomisation should be terminated with a probability of about 95%. Overall response rates will be controlled by a restricted sequential procedure.
Patients achieving at least a partial remission after R-FC or R-CHOP will be randomised for interferon maintenance versus rituximab maintenance in order to evaluate the impact of maintenance therapy in progression free survival.
The improvement expected by the new maintenance with rituximab for progression free survival can be expressed by reduction of relative risk (rr). Since a risk reduction to 60% was observed for indolent lymphomas by interferon maintenance, this seems to be a clinical relevant improvement for the new maintenance therapy. For a working significance level alpha=0.05 and a power of 95% the number of events (relapse or death) necessary for a two sided fixed sample trial is about 200. During this study the progression free survival in patients after successful initial therapy will be monitored by an equivalent restricted sequential procedure with a maximum number of 240 observation.
In order to evaluate the impact of initial therapy and maintenance therapy on overall survival in this patients, a total follow up of about 15 years for this study is expected.
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 | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Interferon-alpha, Drug: pegylated formula Interferon-alpha 2b, Procedure: chemotherapy: R-CHOP, Procedure: Interferon maintenance1. randomisation: R-CHOP 2. randomisation: IFN maintenance |
| 2 | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Fludarabine, Procedure: chemotherapy: R-FC, Procedure: Rituximab maintenance1. randomisation: R-FC 2. randomisation: Rituximab maintnenance |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven mantle cell lymphoma according to the World Health Organization (WHO) classification, preferably confirmed by central pathology review before entering the study
- Clinical stage II, III or IV
- Previously untreated patients
- Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
- WHO performance grade 0, 1 or 2
Key exclusion criteria (17 listed)
- WHO performance of 3 or more
- Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- Leukocytes <2.0x 10^9/l or thrombocytes <100x 10^9/l, unless clearly related to mantle cell lymphoma (MCL) bone marrow infiltration
- Patients previously treated for lymphoma
- Patients without measurable lesions; if, for example only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of a CR
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 |
|---|---|---|
| Rituximabantibody | Drug | 1, 2 |
| Cyclophosphamidechemotherapy | Drug | 1, 2 |
| Doxorubicinchemotherapy | Drug | 1 |
| Vincristinechemotherapy | Drug | 1 |
| Prednisonecoricosteroide | Drug | 1 |
| Fludarabinechemotherapy | Drug | 2 |
| Interferon-alphacytokine | Drug | 1 |
| pegylated formula Interferon-alpha 2bcytokine | Drug | 1 |
| chemotherapy: R-CHOPimmuno-chemotherapy | Procedure or surgery | 1 |
| chemotherapy: R-FCimmuno-chemotherapy | Procedure or surgery | 2 |
| Interferon maintenancecytokine | Procedure or surgery | 1 |
| Rituximab maintenanceantibody | Procedure or surgery | 2 |
Primary outcome
First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate
Second randomisation: progression-free survival after end of initial chemotherapy
6 secondary outcomes
Survival after registration / first randomisation / second randomisation
Survival after start / end of initial therapy
Time to treatment failure after start of initial therapy
Progression free survival after registration / first randomisation / second randomisation
Side-effects of initial therapy
Side-effects of maintenance therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Results publication: PubMed 22873532Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Prochazka V, Di Raimondo F, Ribrag V, Uppenkamp M, Andre M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. doi: 10.1056/NEJMoa1200920.
- Derived from this study: PubMed 37992261Hoster E, Delfau-Larue MH, Macintyre E, Jiang L, Stilgenbauer S, Vehling-Kaiser U, Salles G, Thieblemont C, Tilly H, Wirths S, Feugier P, Hubel K, Schmidt C, Ribrag V, Kluin-Nelemans JC, Dreyling M, Pott C; European MCL MRD Working Group and the European MCL Network. Predictive Value of Minimal Residual Disease for Efficacy of Rituximab Maintenance in Mantle Cell Lymphoma: Results From the European Mantle Cell Lymphoma Elderly Trial. J Clin Oncol. 2024 Feb 10;42(5):538-549. doi: 10.1200/JCO.23.00899. Epub 2023 Nov 22.
- Derived from this study: PubMed 31804876Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Geisler CH, Trneny M, Stilgenbauer S, Kaiser F, Doorduijn JK, Salles G, Szymczyk M, Tilly H, Kanz L, Schmidt C, Feugier P, Thieblemont C, Zijlstra JM, Ribrag V, Klapper W, Pott C, Unterhalt M, Dreyling MH. Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial. J Clin Oncol. 2020 Jan 20;38(3):248-256. doi: 10.1200/JCO.19.01294. Epub 2019 Dec 5.
- Derived from this study: PubMed 24687837Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. doi: 10.1200/JCO.2013.52.2466. Epub 2014 Mar 31.
- Derived from this study: PubMed 20032498Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, Plonquet A, Siebert R, Callet-Bauchu E, Andersen N, van Dongen JJ, Klapper W, Berger F, Ribrag V, van Hoof AL, Trneny M, Walewski J, Dreger P, Unterhalt M, Hiddemann W, Kneba M, Kluin-Nelemans HC, Hermine O, Macintyre E, Dreyling M. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010 Apr 22;115(16):3215-23. doi: 10.1182/blood-2009-06-230250. Epub 2009 Dec 23.
- official webpage of the European MCLNetworkLink 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.
Hanneke C. Kluin-Nelemans, PhD principal investigator
University Hospital Groningen, Dept. of Hematology
Martin Dreyling, PhD study chair
University Hospital Grosshadern/LMU, Dept. of Medicine III
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Lymphoma, Mantle-Cell, run by European Mantle Cell Lymphoma Network at 7 sites in 7 countries.
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 7 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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia, Denmark, France, Germany, Italy and 2 more countries. 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?
First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate. The study lists 2 primary outcomes in all. 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 NCT00209209, which also lists 5 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 7 Mar 2017.