A Phase 1/2 interventional study of Ixazomib and Ixazomib in Mantle-Cell Lymphoma, sponsored by PrECOG, LLC.. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by PrECOG, LLC. · Phase 1/2, Interventional, and Treatment
Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib.
Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy.
Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on proteasome to provide this protein metabolism (turnover) function to regulate their growth and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome and disrupting protein metabolism. This may help to slow down the growth of cancer or may cause cancer cells to die.
The purpose of this study is to see whether the addition of ixazomib to ibrutinib chemotherapy is effective in treating people who have relapsed or refractory MCL and to examine the side effects associated with ixazomib in combination with ibrutinib.
MCL is a rare subtype of non-Hodgkin lymphoma that is considered incurable with conventional therapy. For relapsed patients, Ibrutinib, lenalidomide, and bortezomib are all approved by the FDA but are not curative. Novel approaches are required to improve outcomes for patients with relapsed/refractory MCL.
This is an open-label study that will be done in 2 phases. Phase I will test different doses of ixazomib and ibrutinib to determine the maximum safe and tolerated dose. In Phase I, patients who have already received ibrutinib, may participate if they meet certain criteria (i.e., have not received ibrutinib for at least 3 months).
Phase II will find out the effects, good and/or bad, of ixazomib in combination with ibrutinib. In Phase II, patients will be separated into 2 groups, patients who have never received a Bruton's Tyrosine Kinase (BTK) inhibitor and patients who have received a BTK inhibitor. This study is designed to examine the effectiveness of this drug in treating patients with MCL.
Patients will be treated until progression or unacceptable toxicity.
Tumor assessments will be performed approximately every 3 months for the first year of treatment, then every 6 months until progression.
Mandatory bone marrow and tumor tissue samples (i.e., obtained during a previous procedure or biopsy) are required at baseline. Mandatory research blood samples will also be collected.
1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.
This study's enrollment of 43 is above the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →PrECOG, LLC. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ function as measured by the following criteria
Patients may not have another that could interfere with the evaluation of safety or efficacy of this combination. Patients with a prior malignancy will be allowed without study chair approval in the following circumstances:
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
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.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
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.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib
Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.
Also known as: Ninlaro
Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
Also known as: Ninlaro
Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
Also known as: Imbruvica
Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
Also known as: Imbruvica
Phase I: Dose Limiting Toxicities (DLT) Rate
To determine the maximum tolerable dose (MTD) of ixazomib (mg) in combination with ibrutinib (mg) in patients with relapsed/refractory mantle cell lymphoma (MCL) using DLT endpoint.
Time frame: 1 month
Phase II: Complete Response Rate
CR rate will be the defined as the percentage of patients achieving CR as confirmed by bone marrow biopsy within the first 12 months of initiating treatment. Response to treatment was assessed using the Lugano classification criteria. Patients completed a PET/CT at the time of study enrollment and were restaged at cycles 3, 6, 9, and 12, and then every 6 months while on study therapy. All patients with suspected CR who had bone marrow involvement at screening underwent a bone marrow biopsy to confirm response.
Time frame: 12 months
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Number of patients with abnormal laboratory values and/or adverse events (defined as a new untoward medical occurrence or worsening of a pre-existing medical condition) related to study treatment. Grades refer to the severity of the adverse event, where grade 1 through 5 signifies mild, moderate, severe, life-threatening, and death respectively.
Time frame: Phase I: 12 months; Phase II: 36 months
Overall Response Rate (ORR)
ORR assessed in accordance with Lugano classification
Time frame: Phase I: 12 months; Phase II: 12 months
Progression-Free Survival (PFS)
PFS assessed in accordance with Lugano classification
Time frame: Phase I & II: 48 months
Overall Survival (OS)
OS assessed during clinic visit or by reaching out to patients to confirm vital status.
Time frame: Phase I & II: 48 months
| Milestone | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Started | 3 | 9 | 4 | 27 |
| Completed | 3 | 9 | 4 | 27 |
| Not completed | 0 | 0 | 0 | 0 |
To determine the maximum tolerable dose (MTD) of ixazomib (mg) in combination with ibrutinib (mg) in patients with relapsed/refractory mantle cell lymphoma (MCL) using DLT endpoint.
| Participants | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) |
|---|---|---|
| Dose Limiting Toxicity = No | 3 | 5 |
| Dose Limiting Toxicity = Yes | 0 | 1 |
| Unevaluable for Dose Limiting Toxicity | 0 | 3 |
CR rate will be the defined as the percentage of patients achieving CR as confirmed by bone marrow biopsy within the first 12 months of initiating treatment. Response to treatment was assessed using the Lugano classification criteria. Patients completed a PET/CT at the time of study enrollment and were restaged at cycles 3, 6, 9, and 12, and then every 6 months while on study therapy. All patients with suspected CR who had bone marrow involvement at screening underwent a bone marrow biopsy to confirm response.
| Participants | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|
| Complete Response | 0 | 11 |
| Partial Response | 2 | 10 |
| Stable Disease | 1 | 0 |
| Progressive Disease | 1 | 6 |
| Unevaluable | 0 | 0 |
Number of patients with abnormal laboratory values and/or adverse events (defined as a new untoward medical occurrence or worsening of a pre-existing medical condition) related to study treatment. Grades refer to the severity of the adverse event, where grade 1 through 5 signifies mild, moderate, severe, life-threatening, and death respectively.
| Participants | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Grade 1 | 0 | 0 | 0 | 1 |
| Grade 2 | 0 | 1 | 1 | 6 |
| Grade 3 | 3 | 7 | 3 | 18 |
| Grade 4 | 0 | 1 | 0 | 1 |
| Grade 5 | 0 | 0 | 0 | 1 |
ORR assessed in accordance with Lugano classification
| Participants | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Complete (CR) or Partial Response (PR) | 2 | 6 | 2 | 21 |
| Non-CR/-PR | 1 | 3 | 2 | 6 |
PFS assessed in accordance with Lugano classification
| Months | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Progression-Free Survival (PFS) | 17.12 (2.56 to 36.44) | 27.43 (5.78 to 29.17) | 14.16 (2.14 to 14.16) | 29.83 (8.28 to 35.12) |
OS assessed during clinic visit or by reaching out to patients to confirm vital status.
| Months | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Overall Survival (OS) | 27.01 (20.01 to 51.15) | 47.74 (25.17 to 47.74) | 29.17 (14.16 to 37.06) | 35.68 (29.83 to 35.68) |
Collected over Adverse event data was collected after each treatment cycle and for 30 days beyond treatment for up to 60 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I: Ixazomib & Ibrutinib (Dose Level 1) | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Phase I: Ixazomib & Ibrutinib (Dose Level 2) | 4/9 (44.4%) | 7/9 (77.8%) | 9/9 (100%) |
| Phase II: Ixazomib & BTK Pre-Treated | 1/4 (25%) | 1/4 (25%) | 4/4 (100%) |
| Phase II: Ixazomib & BTK-Naive | 5/27 (18.5%) | 10/27 (37%) | 27/27 (100%) |
| Event | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 1/3 | 1/9 | 0/4 | 2/27 |
| Lung infectionInfections and infestations | 1/3 | 1/9 | 0/4 | 0/27 |
| Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 | 0/9 | 0/4 | 0/27 |
| PyrexiaGeneral disorders | 1/3 | 0/9 | 0/4 | 0/27 |
| Haemolytic anaemiaBlood and lymphatic system disorders | 0/3 | 0/9 | 1/4 | 0/27 |
| Acute kidney injuryRenal and urinary disorders | 0/3 | 1/9 | 0/4 | 0/27 |
| Hepatic failureHepatobiliary disorders | 0/3 | 1/9 | 0/4 | 0/27 |
| Herpes zosterInfections and infestations | 0/3 | 1/9 | 0/4 | 0/27 |
| Pneumonia fungalInfections and infestations | 0/3 | 1/9 | 0/4 | 0/27 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/9 | 0/4 | 0/27 |
| Event | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive |
|---|---|---|---|---|
| FatigueGeneral disorders | 1/3 | 4/9 | 3/4 | 16/27 |
| ContusionInjury, poisoning and procedural complications | 2/3 | 3/9 | 0/4 | 7/27 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 4/9 | 2/4 | 15/27 |
| NauseaGastrointestinal disorders | 0/3 | 3/9 | 1/4 | 15/27 |
| Platelet Count DecreasedInvestigations | 1/3 | 2/9 | 2/4 | 10/27 |
| RashSkin and subcutaneous tissue disorders | 1/3 | 4/9 | 1/4 | 6/27 |
| Upper Respiratory Tract InfectionInfections and infestations | 1/3 | 4/9 | 0/4 | 2/27 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/3 | 1/9 | 0/4 | 9/27 |
| DizzinessNervous system disorders | 1/3 | 2/9 | 0/4 | 5/27 |
| HeadacheNervous system disorders | 1/3 | 0/9 | 0/4 | 7/27 |
Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy. Ixazomib is in a class of medications called proteasome inhibitors. It may help to slow down the growth of cancer or may cause cancer cells to die.
| Age, Categorical(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 1 | 6 | 9 |
| >=65 years | 2 | 8 | 3 | 21 | 34 |
| Age, Continuous(years) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| Median | 67 (52 to 73) | 73 (63 to 84) | 74 (58 to 77) | 70 (53 to 80) | 70 (52 to 84) |
| Sex: Female, Male(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| Female | 1 | 2 | 0 | 8 | 11 |
| Male | 2 | 7 | 4 | 19 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 9 | 4 | 27 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 0 | 1 |
| White | 3 | 7 | 4 | 25 | 39 |
| More than one race | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| United States | 3 | 9 | 4 | 27 | 43 |
| Ann Arbor Stage(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| Stage IE | 0 | 0 | 0 | 1 | 1 |
| Stage II | 0 | 2 | 0 | 2 | 4 |
| Stage III | 1 | 1 | 0 | 1 | 3 |
| Stage IV | 2 | 6 | 4 | 23 | 35 |
| ECOG Performance Status(Participants) | Phase I: Ixazomib & Ibrutinib (Dose Level 1) | Phase I: Ixazomib & Ibrutinib (Dose Level 2) | Phase II: Ixazomib & BTK Pre-Treated | Phase II: Ixazomib & BTK-Naive | Total |
|---|---|---|---|---|---|
| 0 | 1 | 4 | 3 | 19 | 27 |
| 1 | 2 | 4 | 1 | 8 | 15 |
| 2 | 0 | 1 | 0 | 0 | 1 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Data is proprietary.
Ran from Aug 2018 to primary completion in Sep 2022, 49 months.
Results were first posted in Jan 2024, 1 year 3 months after primary completion.
Of 51 non-industry phase 1/2 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 78 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 122. This study's 49 months is below that.
Counting every sponsor, half of 77 studies reached it within 75 months; a quarter within 45 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ixazomib · Ibrutinib
PrECOG, LLC.