Mantle Cell LymphomaPhase 2NCT02682641
Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL
A Phase 2 study testing IBRUTINIB and Rituximab in people with Mantle Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 sites in Spain.
Trial summary
Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- IBRUTINIB and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesSpain
- Study dates
- 18 May 2016to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
- Age 18 years or older.
- Subjects must not have received any prior therapies (excluding diagnostic splenectomy).
- Asymptomatic patients.
- Ann Arbor clinical stages I-IV.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (0-1).
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- Subjects with a non-nodal MCL presentation with mainly bone marrow or peripheral blood involvement.
- Other asymptomatic clinical presentations are acceptable in case of low tumor burden, including nodal MCL with lymph node enlargement ≤3 cm in the maximum diameter and with low proliferation index (Ki-67 ≤ 30%).
- The following laboratory values at screening: a) Neutrophil count ≥ 1×10e9/L, Hemoglobin level ≥ 100 g/L or platelet count ≥100×10e9/L; b) Transaminases (AST and ALT) ≤ 3 x ULN. c)Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; d) Creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 40 mL/min/1.73 m2.
- Stable disease without evidence of clinical progression criteria for at least 3 months. Patients in prolonged therapeutic abstention may be included.
- Women of childbearing potential and men who are sexually active must be practising a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
- Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
Who cannot join
- Aggressive histological variants: blastic and pleomorphic variants (blastoid).
- Proliferation index measured by Ki-67 > 30%.
- B-cell monoclonal lymphocytosis with MCL phenotype
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2. Presence of B symptoms or any relevant symptoms related to the MCL.
- 6. Nodal clinical forms with lymph node enlargement >3 cm (maximum diameter). 7. Cytopenias attributable to MCL: Neutrophil count < 1×10e9/L, Hemoglobin level < 100 g/L or platelet count < 100×10e9/L.
- 8. Organ dysfunction related to MCL including creatinine level > 2 x ULN or altered liver biochemistry (> 3x ULN).
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- 9. Gradual increase in different determinations of serum LDH attributable to MCL that exceeds 20% of the ULN.
- 10. Known CNS infiltration. 11. Subjects with expected therapy requirement for MCL in a short time (< 3 months) 12. Patients with active hepatitis B or C infection or HIV infection. Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) will be excluded with the following exceptions. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing or antiviral prophylaxis. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- 13. Anticoagulation requirement with vitamin K antagonists. 14. Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion.
- 15. Required medication with strong CYP3A4/5 inhibitors 16. Any serious comorbidity that makes the patient unacceptable for receiving the treatment.
- 17. Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.
- 18. Pregnancy or lactation. 19. Major surgery within 4 weeks of inclusion. 20. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- 21. Vaccinated with live, attenuated vaccines within 4 weeks of randomization. 22. Uncontrolled systemic infection requiring intravenous (IV) antibiotics. 23. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona
Institut Català d'Oncologia
Barcelona, Barcelona
Hospital Universitario de Burgos
Burgos, Burgos
Hospital General Universitario Santa Lucía
Cartagena, Murcia
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario Ramon y Cajal
Madrid, Madrid
MD Anderson Cancer Center
Madrid, Madrid
Hospital Costa del Sol
Marbella, Málaga
Hospital Universitario Clinico de Salamanca
Salamanca
Hospital Universitario Virgen del Rocio
Seville, Sevilla
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona
Hospital Clínico de Valencia
Valencia, Valencia
About this study
Official title: Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma
Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL.
An extensive biological study will be conducted in order to further characterize this population of MCL patients and evaluate the response obtained with the mutational profile of the tumor.
Read the detailed description
Patients with mantle cell lymphoma (MCL) have a median survival of 3-5 years despite treatment. Indeed, the best therapeutic approach for different patients with MCL remains to be established, coexisting different options of immunochemotherapy regimes which may include autologous transplantation in first-line treatment or rituximab maintenance.
Moreover, last years MCL starts to be recognized as a heterogeneous disease both from biological and clinical stand points. For instance, MCL cases with a non-nodal clinical presentation, usually have distinctive biological features such as SOX-11 negativity, hypermutated IGHV genes and a low number of genetic lesions associated. The outcome of these cases is much more favourable compared to conventional MCL, reaching median survivals over 7 to 10 years even receiving less intensive treatments. In addition to that, up to 30% of the patients with newly diagnosed MCL can be safely deferred from initial therapy until progression . Therapeutic abstention may be prolonged for more than one year in 50% of cases. These patients usually show longer survivals from the start of treatment compared to patients immediately treated after diagnosis. Therefore, all these observations indicate that there are indolent clinical forms in MCL, so its clinico-biological identification is crucial to tailor treatment appropriately. However, at present there is no consensus on the diagnostic criteria or treatment recommendations in cases of indolent MCL. This results in difficulties for the identification of these forms in the clinical practice as well as with a certain therapeutic in definition, as indolent forms of MCL can be treated either with therapeutic abstention until progression or receive immediate treatment with conventional or more intensive immuno-chemotherapy regimes, which may even include an autologous hematopoietic stem cell transplantation. With the emergence of new biological agents in the therapeutic arsenal of MCL arises the question whether a completely different approach with new drugs and chemotherapy-free could be more appropriate in selected subsets of patients such as indolent MCL forms.
- Conditions
- Mantle Cell Lymphoma
- 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.
IBRUTINIBDrug
Also called Imbruvica
Ibrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity.
RituximabDrug
Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1, 4 doses). Rituximab 375 mg/m2 iv, day one of every other cycle for 4 doses (cycle 3, 5, 7 and 9).
| Study group | Role | What they receive |
|---|---|---|
| IBRUTINIB + RITUXIMAB | Experimental | Subjects will receive the ibrutinib in combination with rituximab according to the following schedule:
* Ibrutinib 560 mg daily po until disease progression or unacceptable toxicity. In case of sustained negative MRD (at least for 6 months) after 2 years of continuous therapy, ibrutinib will be discontinued.
* Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1). Rituximab 375 mg/m2 iv, day one of every cycle 3, 5, 7 and 9. Receives: Drug: IBRUTINIB; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete remission
Percentage of patients who are alive and in complete response at 12 months from the date of treatment initiation. All patients will be evaluated with PET- CT and bone marrow biopsy at that time.
Measured: 12 months
Secondary outcomes (8)
Overall Response Rate (OR)
Including complete response and partial response according to the International Response Criteria for Non- Hodgkin Lymphoma
Measured: 12 months
Progression Free Survival
Percentage of patients without progression of disease
Measured: 7 years
Response Duration
Length of time between
Measured: 7 years
Minimal residual disease (MRD)
Proportion of subjects who are MRD negative (ie, less than the lower limit of detection for the MRD assay).
Measured: within 12 months after initiation of study treatment
Overall survival
Percentage of patients alive from first dose of treatment to end of follow-up.
Measured: 7 years
Adverse Events (AEs), Serious Adverse Events (SAES) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Number of events classified according to the Common Toxicity Criteria of the National Cancer Institute (CTC AE V 4.03).
Measured: 7 years
Score of the EORTC quality of life questionnaire QLQ-30
Health related quality of life questionnaire
Measured: 12 months
Secore of the FACT-LYM
Health related quality of life questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start18 May 2016
- Primary completionDec 2019
- Study completionDec 2029 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Responsible party
- Sponsor
- Investigators
- Eva Giné, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682641
- Sponsor's protocol ID
- GELTAMO-IMCL-2015
- Other IDs
- 2015-004158-17, 2015
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2016
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gine E, de la Cruz F, Jimenez Ubieto A, Lopez Jimenez J, Martin Garcia-Sancho A, Terol MJ, Gonzalez Barca E, Casanova M, de la Fuente A, Marin-Niebla A, Muntanola A, Gonzalez-Lopez TJ, Aymerich M, Setoain X, Cortes-Romera M, Rotger A, Rodriguez S, Medina Herrera A, Garcia Sanz R, Nadeu F, Bea S, Campo E, Lopez-Guillermo A. Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2022 Apr 10;40(11):1196-1205. doi: 10.1200/JCO.21.02321. Epub 2022 Jan 14.
PubMed 35030036
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02682641
- Acronym / sponsor ID
- GELTAMO-IMCL-2015
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Study start
- 18 May 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Feb 2016 (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.
Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL.
An extensive biological study will be conducted in order to further characterize this population of MCL patients and evaluate the response obtained with the mutational profile of the tumor.
Detailed description
Patients with mantle cell lymphoma (MCL) have a median survival of 3-5 years despite treatment. Indeed, the best therapeutic approach for different patients with MCL remains to be established, coexisting different options of immunochemotherapy regimes which may include autologous transplantation in first-line treatment or rituximab maintenance.
Moreover, last years MCL starts to be recognized as a heterogeneous disease both from biological and clinical stand points. For instance, MCL cases with a non-nodal clinical presentation, usually have distinctive biological features such as SOX-11 negativity, hypermutated IGHV genes and a low number of genetic lesions associated. The outcome of these cases is much more favourable compared to conventional MCL, reaching median survivals over 7 to 10 years even receiving less intensive treatments. In addition to that, up to 30% of the patients with newly diagnosed MCL can be safely deferred from initial therapy until progression . Therapeutic abstention may be prolonged for more than one year in 50% of cases. These patients usually show longer survivals from the start of treatment compared to patients immediately treated after diagnosis. Therefore, all these observations indicate that there are indolent clinical forms in MCL, so its clinico-biological identification is crucial to tailor treatment appropriately. However, at present there is no consensus on the diagnostic criteria or treatment recommendations in cases of indolent MCL. This results in difficulties for the identification of these forms in the clinical practice as well as with a certain therapeutic in definition, as indolent forms of MCL can be treated either with therapeutic abstention until progression or receive immediate treatment with conventional or more intensive immuno-chemotherapy regimes, which may even include an autologous hematopoietic stem cell transplantation. With the emergence of new biological agents in the therapeutic arsenal of MCL arises the question whether a completely different approach with new drugs and chemotherapy-free could be more appropriate in selected subsets of patients such as indolent MCL forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBRUTINIB + RITUXIMAB | Experimental | Drug: IBRUTINIB, Drug: RituximabSubjects will receive the ibrutinib in combination with rituximab according to the following schedule: * Ibrutinib 560 mg daily po until disease progression or unacceptable toxicity. In case of sustained negative MRD (at least for 6 months) after 2 years of continuous therapy, ibrutinib will be discontinued. * Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1). Rituximab 375 mg/m2 iv, day one of every cycle 3, 5, 7 and 9. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
- Age 18 years or older.
- Subjects must not have received any prior therapies (excluding diagnostic splenectomy).
- Asymptomatic patients.
- Ann Arbor clinical stages I-IV.
Key exclusion criteria (13 listed)
- Aggressive histological variants: blastic and pleomorphic variants (blastoid).
- Proliferation index measured by Ki-67 > 30%.
- B-cell monoclonal lymphocytosis with MCL phenotype
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2. Presence of B symptoms or any relevant symptoms related to the MCL.
- 6. Nodal clinical forms with lymph node enlargement >3 cm (maximum diameter). 7. Cytopenias attributable to MCL: Neutrophil count < 1×10e9/L, Hemoglobin level < 100 g/L or platelet count < 100×10e9/L.
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 |
|---|---|---|
| IBRUTINIBAlso: ImbruvicaIbrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity. | Drug | IBRUTINIB + RITUXIMAB |
| RituximabRituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1, 4 doses). Rituximab 375 mg/m2 iv, day one of every other cycle for 4 doses (cycle 3, 5, 7 and 9). | Drug | IBRUTINIB + RITUXIMAB |
Primary outcome
Rate of complete remission
Time frame: 12 months
Percentage of patients who are alive and in complete response at 12 months from the date of treatment initiation. All patients will be evaluated with PET- CT and bone marrow biopsy at that time.
8 secondary outcomes
Overall Response Rate (OR)
Time frame: 12 months
Progression Free Survival
Time frame: 7 years
Response Duration
Time frame: 7 years
Minimal residual disease (MRD)
Time frame: within 12 months after initiation of study treatment
Overall survival
Time frame: 7 years
Adverse Events (AEs), Serious Adverse Events (SAES) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Time frame: 7 years
Score of the EORTC quality of life questionnaire QLQ-30
Time frame: 12 months
Secore of the FACT-LYM
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 35030036Gine E, de la Cruz F, Jimenez Ubieto A, Lopez Jimenez J, Martin Garcia-Sancho A, Terol MJ, Gonzalez Barca E, Casanova M, de la Fuente A, Marin-Niebla A, Muntanola A, Gonzalez-Lopez TJ, Aymerich M, Setoain X, Cortes-Romera M, Rotger A, Rodriguez S, Medina Herrera A, Garcia Sanz R, Nadeu F, Bea S, Campo E, Lopez-Guillermo A. Ibrutinib in Combination With Rituximab for Indolent Clinical Forms of Mantle Cell Lymphoma (IMCL-2015): A Multicenter, Open-Label, Single-Arm, Phase II Trial. J Clin Oncol. 2022 Apr 10;40(11):1196-1205. doi: 10.1200/JCO.21.02321. Epub 2022 Jan 14.
- 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.
Eva Giné, MD study chair
Hospital Clinic of Barcelona
15 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 IBRUTINIB and Rituximab in people with Mantle Cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 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 13 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of complete remission (time frame: 12 months). 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 NCT02682641, 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 27 Mar 2026.