A Phase 2 interventional study of IBRUTINIB and Rituximab in Mantle Cell Lymphoma, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Active, not recruiting at 15 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Phase 2, Interventional, and Treatment
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Among 45 studies testing ibrutinib in Lymphoma, Mantle-Cell — 2 open to participants now, 16 under way, 2 of them phase 3. ibrutinib · Lymphoma, Mantle-Cell.
Among the 45 studies testing ibrutinib in Lymphoma, Mantle-Cell, this one is the 17th largest by planned enrollment, is one of 5 that started in 2016, is one of 21 in phase 2, reaches primary completion later than 2 of the 15 other live ones, and was the 21st registered.
1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.
Browse Lymphoma, Mantle-Cell studies →2 of the 45 studies testing ibrutinib in Lymphoma, Mantle-Cell are open now, in 6 countries. Recruiting first, the newest first:
OHSU Knight Cancer Institute · Sites in United States
Ages 18+
Prof. Dr. M. Dreyling (co-chairman) · Sites in Denmark, Germany, Italy and 2 more countries
Ages 18–65
By country, each count listing its studies:
ibrutinib: first FDA approval 2013 (IMBRUVICA), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 125 Lymphoma, Mantle-Cell studies recruiting now, 92 (74%) set no upper age limit and 12 (10%) stop at 75 or younger; 14 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 26 · Phase 3 6 · Phase 4 1
First in 2009; this study’s year is marked. 5 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.
Median enrollment 39 across the 45 interventional studies. Of the 24 that completed or were terminated, 12 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 45 have an industry lead sponsor. The 10 most frequent:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea has 4 studies filed under Lymphoma, Mantle-Cell — fewer than ten, so there is no comparison to draw.
6 of the studies testing ibrutinib in Lymphoma, Mantle-Cell that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01804686Phase 3Janssen Research & Development, LLCA Long-term Extension Study of PCI-32765 (Ibrutinib) | 2026-12-31 |
| NCT01479842Kami Maddocks, MDRituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma | 2026-12-01 |
| NCT03710772M.D. Anderson Cancer CenterIbrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma | 2027-03-22 |
| NCT03153202Joshua BrodyStudy to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL) | 2027-04 |
| NCT02427620M.D. Anderson Cancer CenterIbrutinib, Rituximab, and Consolidation Chemotherapy in Treating Young Patients With Newly Diagnosed Mantle Cell Lymphoma | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 45 studies testing ibrutinib in Lymphoma, Mantle-Cell, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
6. Nodal clinical forms with lymph node enlargement >3 cm (maximum diameter). 7. Cytopenias attributable to MCL: \< 1×10e9/L, level \< 100 g/L or count \< 100×10e9/L.
8. Organ dysfunction related to MCL including creatinine level > 2 x or altered liver biochemistry (> 3x ULN).
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 or C infection or infection. Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test results for (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 /5 inhibitors 16. Any serious comorbidity that makes the patient unacceptable for receiving the treatment.
17. Concomitant or previous 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. 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: IBRUTINIB · Drug: Rituximab
Ibrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity.
Also known as: Imbruvica
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).
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.
Time frame: 12 months
Overall Response Rate (OR)
Including complete response and partial response according to the International Response Criteria for Non- Hodgkin Lymphoma
Time frame: 12 months
Progression Free Survival
Percentage of patients without progression of disease
Time frame: 7 years
Response Duration
Length of time between
Time frame: 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).
Time frame: within 12 months after initiation of study treatment
Overall survival
Percentage of patients alive from first dose of treatment to end of follow-up.
Time frame: 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).
Time frame: 7 years
Score of the EORTC quality of life questionnaire QLQ-30
Health related quality of life questionnaire
Time frame: 12 months
Secore of the FACT-LYM
Health related quality of life questionnaire
Time frame: 12 months
Plan to share: No
Ran from May 2016 to primary completion in Dec 2019, 43 months.
Of 153 non-industry phase 2 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's 43 months is below that.
Counting every sponsor, half of 183 studies reached it within 63 months; a quarter within 38 and three quarters within 106.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Ibrutinib · Rituximab
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea