A Phase 2 interventional study of Ibrutinib and Rituximab in Diffuse Large B-Cell Lymphoma, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Completed at 17 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Phase 2, Interventional, and Treatment
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Among 26 studies testing ibrutinib in Lymphoma, Large B-Cell, Diffuse — 3 open to participants now, 10 under way, 2 of them phase 3. ibrutinib · Lymphoma, Large B-Cell, Diffuse.
Among the 26 studies testing ibrutinib in Lymphoma, Large B-Cell, Diffuse, this one is the 11th largest by enrollment, is one of 5 that started in 2016, is one of 8 in phase 2, and was the 12th registered.
1,869 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 357 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →3 of the 26 studies testing ibrutinib in Lymphoma, Large B-Cell, Diffuse are open now, in 1 country. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Yazeed Sawalha · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
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 266 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 51 (19%) stop at 75 or younger; 25 take children under 18; 7 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.
26 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 15 · Phase 2 14 · Phase 3 3
First in 2011; 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 enrollment of 64 is above the median of 45 across 1,499 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 44 across the 26 interventional studies. Of the 14 that completed or were terminated, 5 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 26 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 8 studies filed under Lymphoma, Large B-Cell, Diffuse — fewer than ten, so there is no comparison to draw.
5 of the studies testing ibrutinib in Lymphoma, Large B-Cell, Diffuse 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 |
| NCT03960840Novartis PharmaceuticalsPhase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL | 2027-06-30 |
| NCT03223610National Cancer Institute (NCI)Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma | 2027-08-12 |
| NCT06536049Yazeed SawalhaEpcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma | 2027-08-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 26 studies testing ibrutinib in Lymphoma, Large B-Cell, Diffuse, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Multicentric phase II trial to evaluate efficacy and safety of ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maintenance in patients with refractory/relapsed non-GCB DLBCL non candidates to autologous stem-cell transplantation (ASCT) An extensive biological study will be conducted in order to further characterize this population of DLBCL patients and correlate the response obtained with the biological profile of the tumor.
The use of highly effective rituximab-containing therapy for treating diffuse large B-cell lymphoma (DLBCL) makes it more difficult to salvage relapsed or refractory patients. In addition, patients with advanced age or significant comorbidities, who are consequently not candidates for high-dose consolidative therapy, have a very poor prognosis. Prospective studies investigating new salvage regimens are essential.
The combination of rituximab, gemcitabine and oxaliplatin (R-GEMOX) is an effective salvage regimen for patients with relapsing or refractory DLBCL, with a favourable toxicity profile for unfit and/or elderly patients. Ibrutinib, an oral Bruton's tyrosine kinase inhibitor, is a potent killer of ABC DLBCL cell lines in vitro and in xenografts.
It is expected that the combination of ibrutinib with R-GEMOX-Dexa could be effective and well tolerated. Thus, it is proposed an open-label, non-randomized, multicentre, phase II trial, to investigate the safety and efficacy of the combination of ibrutinib with rituximab, gemcitabine, oxaliplatine and dexamethasone followed by ibrutinib maintenance as salvage therapy for patients with relapsed or refractory non-GCB DLBCL non-candidates to stem cell transplant.
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.
Non-germinal center B-cell-like (GCB) subtype according to Hans algorithm (local laboratories).
-A central review will be performed for confirmation of the germinal center B-cell-like, however even when negative results are reported, the patient will still be part of the study if clinical benefit after cycle 4 is documented (stable disease, partial response and complete response).
disease after:
Hematology values must be within the following limits:
Biochemical values within the following limits:
Exclusion Criteria:
Candidates to stem cell transplant.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
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.
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.
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.
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.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
Subjects will receive Ibrutinib with R-GEMOX-Dexa followed by Ibrutinib maintenance according to: Induction phase: * Rituximab 375 mg/m2 IV day 1 * Gemcitabine 1000 mg/m2 IV on day 1 or 2 (at investigator discretion). * Oxaliplatine 100 mg/m2 on day 1 or 2 (after Gemcitabine administration); * Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3. * Ibrutinib 560 mg daily for 14 days. Responding patients will receive 2 (if CR) or 4 (if PR) additional cycles every 14 days.Patients with SD and ABC profile will receive 4 additional cycles. Maintenance phase: Responding patients will receive Ibrutinib 560 mg daily - Continuous cycles until a maximum of 2 years, disease progression or unacceptable toxicity.
Drug: Ibrutinib · Drug: Rituximab · Drug: Gemcitabine · Drug: Oxaliplatin · Drug: Dexamethasone
Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
Rituximab 375 mg/m2 IV day 1 during 4 cycles.
Gemcitabine 1000 mg/m2 IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
Oxaliplatin 100 mg/m2 (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
Overall Response (OR) Rate
Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
Time frame: Treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
CR Rate During Induction and Maintenance Phases.
Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months
Time frame: Complete treatment responses will be evaluated 30 days after end of study treatment which can be occurred after 2 years and 4 months
Response Duration
Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease.
Time frame: Response duration will be evaluated at any time during the study when tumor response is documented or after end of study treatment which can be occurred after 2 years and 4 months.
Progression Free Survival
Progression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow.
Time frame: Progression free survival will be evaluated at any time during the study when first documentation of recurrence, progression, or death or after end of study treatment which can be occurred after 2 years and 4 months
Event-free Survival
Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0
Time frame: 2 years and 4 months.
Overall Survival
Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time.
Time frame: 2 years
Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone
Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC
Time frame: 2 years and 4 months
64 patients from 15 different hospitals were registered.
| Milestone | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Started | 64 |
| Completed | 64 |
| Not completed | 0 |
Overall Response (OR) rate (complete remission + partial response) measured by PET(Positron Emission Tomography)/CT image scan. OR will be assessed by Lugano Classification: Revised Criteria for Response Assessment.
| Participants | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Overall Response (OR) Rate | 36 |
Complete treatment responses evaluation during 21-35 days after initiation of 6 or 8 cycle of study treatment (depend of treatment responses obtained from cycle 4) and 30 days after end of study treatment which can be occurred after 2 years and 4 months
| Participants | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| CR Rate During Induction and Maintenance Phases. | 25 |
Response duration defined as the time from the documentation of tumor response to disease progression or death, in the event of no documented recurrence, or start of a new anti - lymphoma treatment because of refractory or persistent disease.
| months | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Response Duration | 6.5 (0.0 to 38.3) |
Progression free survival defined as the time between start of treatment and the first documentation of recurrence, progression, or death in the event of no documented recurrence, or start of a new anti - lymphoma treatment, due a refractory or persistent disease. Progression is defined using Lugano Classification for response assessment for Non-Hodgkin Lymphoma, defined as Score of 4 or 5 with an increase in uptake intensity over baseline period for Individual lymph nodes/target lymph node masses; New areas of FDG avidity consistent with lymphoma at mid- or end-of-treatment assessment for Extranodal injuries; new injuries; New or recurrent areas of FDG avidity in bone marrow.
| months | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Progression Free Survival | 4.1 (2.2 to 6.1) |
Event-free survival defined as the time between start of treatment and the first documentation of adverse events and serious adverse events graded according to NCI CTCAE v4.0
| months | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Event-free Survival | 4.03 (2.5 to 5.6) |
Overall survival is defined as the time between the start of treatment and death from any cause. Patients that are withdrawn from the trial or lost of follow-up, will be censored with the date of last contact. Patients who are still alive at the end of the study will be censored at that time.
| months | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Overall Survival | 11.67 (7 to 16.3) |
Safety and tolerability will be assessed during any phase of study treatment and 30 days after end of study treatment which can be occurred after 2 years and 4 months and will be classified according to the Common Toxicity CNC
| Participants | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Percentage of Participants That Present Treatment-Related Adverse Events Oxaliplatin and Dexamethasone | 55 |
Collected over 2 years and 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrutinib -R-GEMOX-Dexa | 46/64 (71.9%) | 33/64 (51.6%) | 63/64 (98.4%) |
| Event | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Diarrhoea - Grade 3Gastrointestinal disorders | 2/64 |
| Fever - Grade 3General disorders | 2/64 |
| Fracture - Grade 3Injury, poisoning and procedural complications | 2/64 |
| Respiratory failure - Grade 3Respiratory, thoracic and mediastinal disorders | 2/64 |
| Abdominal pain - Grade 3Gastrointestinal disorders | 1/64 |
| Akathisia - Grade 3Nervous system disorders | 1/64 |
| Anemia - Grade 3Blood and lymphatic system disorders | 1/64 |
| Back Pain - Grade 3Musculoskeletal and connective tissue disorders | 1/64 |
| Confusion - Grade 3Nervous system disorders | 1/64 |
| Diarrhoea - Grade 2Gastrointestinal disorders | 1/64 |
| Event | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Platelet count decreasedBlood and lymphatic system disorders | 39/64 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 22/64 |
| DiarrhoeaGastrointestinal disorders | 20/64 |
| AnemiaBlood and lymphatic system disorders | 14/64 |
| NauseaGeneral disorders | 14/64 |
| Lymphocyte count decreaseBlood and lymphatic system disorders | 10/64 |
| ParesthesiaNervous system disorders | 8/64 |
| FatigueGeneral disorders | 7/64 |
| VomitingGastrointestinal disorders | 6/64 |
| HypomagnesemiaBlood and lymphatic system disorders | 4/64 |
| Age, Continuous(years) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Median | 67.4 (24.5 to 83.7) |
| Sex: Female, Male(Participants) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Female | 26 |
| Male | 38 |
| Race and Ethnicity Not Collected(Participants) | Ibrutinib -R-GEMOX-Dexa |
|---|
| Region of Enrollment(participants) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Spain | 64 |
| ECOG-PS(Participants) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| 0 | 23 |
| 1 | 31 |
| 2 | 10 |
| DLBCL type(Participants) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| DLBCL without specification | 60 |
| DLBCL rich in T lymphocytes | 3 |
| Follicular lymphoma | 1 |
| Previous lines of treatment(Previous lines of treatment) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| Median | 2 (1 to 5) |
| International prognostic index (IPI)(Participants) | Ibrutinib -R-GEMOX-Dexa |
|---|---|
| 0-1 | 6 |
| 2-3 | 43 |
| 4-5 | 13 |
| Unk | 2 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2016 to primary completion in Nov 2018, 31 months.
Results were first posted in Oct 2024, 5 years 11 months after primary completion.
Of 210 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's 31 months is below that.
Counting every sponsor, half of 264 studies reached it within 53 months; a quarter within 35 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ibrutinib · Rituximab · Gemcitabine · Oxaliplatin · Dexamethasone
Lymphoma, Large B-Cell, Diffuse →
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea