CompletedNCT03323151PrE0404Updated Jun 25, 2026Results posted

A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma

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

Phase: Phase 1/2
Study type: Interventional
Enrollment: 43
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Mantle-Cell Lymphoma

Browse trials for

Lymphoma, Mantle-Cell 781

Keywords

Relapsed Mantle-Cell Lymphoma
Refractory Mantle-Cell Lymphoma
Ixazomib
Ibrutinib
Proteasome Inhibitor
Bruton's Tyrosine Kinase Inhibitor

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Relapsed or refractory, pathologically proven mantle cell lymphoma. Must have a current or prior tissue sample that is IHC positive for cyclin D 1 or that is positive by FISH or cytogenetics for t(11;14).
Must have been refractory to and/or relapsed/progressed after at least 1 prior therapy.
Prior autologous or allogeneic transplant are allowed. Patients may not have active grade II-IV acute graft-versus-host disease (GVHD) or moderate/severe chronic GVHD by NIH criteria and may not require immunosuppressive medications and/or corticosteroids for the management of acute or chronic GVHD.
Phase I: Prior proteasome inhibitor and/or Bruton's tyrosine kinase (BTK) inhibitors are allowed but patients may not have been exposed to the combination of proteasome inhibitor and BTK inhibitor. Patients who have progressed on ibrutinib that are felt to be at high risk for rapid progression on this study shall not be eligible for the phase I portion of the study. NOTE: Ibrutinib pre-treated patients must meet all eligibility criteria AND must have discontinued prior ibrutinib at least 3 months prior to starting study therapy. PHASE I COMPLETED NOVEMBER 25, 2019.
Phase II: Prior proteasome inhibitors allowed. (Please note prior to Version 3.0 of the protocol prior proteasome inhibitor and/or Bruton's tyrosine kinase inhibitors were allowed but patients could not have been exposed to the combination of proteasome inhibitor and BTK inhibitor).
Age ≥ 18 years.
Eastern Oncology Oncology Group (ECOG) performance status of 0-2.
Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent.
Willing to provide archived tumor tissue, bone marrow (if sufficient bone marrow and tumor tissue are available) and blood samples for research.
Adequate organ function as measured by the following criteria
- Absolute Neutrophil Count (ANC) ≥ 750/mm³
- Platelets ˃50,000/mm³
- Serum Creatinine ≤ 2x Upper Limit Normal (ULN)
- ALT and AST ≤ 3x ULN
- Total Bilirubin ≤ 1.5x ULN
Patients must not have received systemic treatment for MCL for at least 14 days prior to enrollment, except for steroids which may be used to manage acute symptoms related to disease up to 48 hours prior to starting study therapy. Radiation therapy must be concluded at least 14 days prior to enrollment.
Women must not be pregnant or breastfeeding since we do not know the effects of ixazomib and ibrutinib on the fetus or breastfeeding child. All sexually active females of childbearing potential must have a blood test to rule out pregnancy within 2 weeks prior to registration.
Sexually active women of child-bearing potential with a non-sterilized male partner and sexually active men must agree to use 2 methods of adequate contraception (hormonal plus barrier or 2 barrier forms) OR abstinence prior to study entry, for the duration of study participation, and for 3 months following last dose of study drugs.
Patients must have resolved all prior non-hematologic toxicities assessed as related to prior therapy to ≤ grade 1.
Patients must have measurable disease (i.e., ≥ 1.5 cm in largest diameter) by conventional imaging modalities. Patients with extranodal involvement as the only measurable site of disease must have a largest diameter ≥ 1.0 cm and must be attributable to active lymphoma in the opinion of the investigator.
Patients may not have current/active Central Nervous System (CNS) involvement with mantle cell lymphoma (patients with prior CNS involvement are eligible as long as they have had no evidence of active CNS disease for at least 6 months).
Patients may not have another malignancy 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:
- Not currently active and diagnosed at least 3 years prior to the date of enrollment.
- Non-invasive diseases such as low risk cervical cancer or any cancer in situ
- Localized disease in which chemotherapy would not be indicated (such as Stage I colon, lung, prostate or breast cancer). Patients with other malignancies not meeting these criteria must be discussed with PrECOG prior to enrollment.
Patients requiring long-term anticoagulation must be managed on an anticoagulant besides warfarin. Patients who require warfarin are not eligible.
Patients with a clinically significant bleeding episode as judged by the investigator within 3 months of registration are not eligible, except patients who suffer bleeding due to trauma.
Patients may not have had major surgery within 14 days, or minor surgery within 3 days, before registration.
Patients may not have any active infection requiring oral or intravenous antimicrobial therapy at the time of therapy initiation. Patients with a recent self-limited infection that has clinically resolved may complete a prescribed course of antimicrobial therapy after study initiation as long as they are asymptomatic with no clinical evidence of infection for at least 7 days prior to treatment. Patients with a recent serious (grade ≥ 3) infection requiring hospitalization must have completed all antimicrobial therapy within 14 days of therapy initiation.
Patients may not have evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure (New York Heart Association (NYHA) class III or higher, unstable angina, or myocardial infarction within the past 6 months. Patients with a history of any significant cardiovascular disease that has been controlled for at least 14 days before registration are allowed (except for patients who have had a myocardial infarction within 6 months).
No systemic treatment, within 14 days before the first dose of ibrutinib with moderate or strong inhibitors of CYP3A (Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, and telithromycin; Moderate Inhibitors: fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprenavir, crizotinib, imatinib, verapamil, ciprofloxacin, grapefruit juice products, and Seville oranges) or strong CYP3A inducers for ibrutinib and ixazomib (carbamazepine, rifampin, phenytoin, St. John's wort).
Patients with ongoing or active systemic infection, active hepatitis B or C virus infection, or known Human Immunodeficiency Virus (HIV) positive are not eligible. Testing is not required in absence of clinical suspicion.
Patients with a history of hepatitis B or C must have a negative peripheral blood Polymerase Chain Reaction (PCR) and may not be positive for Hepatitis B surface antigen. Patients with cirrhosis or other evidence of liver damage due to Hepatitis B or C are not eligible.
Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.
Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
Patients with known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of ixazomib or ibrutinib including difficulty swallowing are not eligible.
Patients with ≥ Grade 2 peripheral neuropathy, or Grade 1 peripheral neuropathy with pain on clinical examination during the screening period are not eligible.
Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial throughout the duration of this study.
As ibrutinib will not be provided by the study, the patient must be able to obtain ibrutinib through other means (i.e., commercially or through patient assistance programs). This must be confirmed prior to registration.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 43 participants (actual)

Study arms

Experimental
Phase I: Ixazomib & Ibrutinib
Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib
Experimental
Phase II: Ixazomib & BTK-Naive
Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib
Experimental
Phase II: Ixazomib & BTK Pre-Treated (Closed 8/7/2020)
Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
Drug: Ixazomib · Drug: Ibrutinib

Interventions

DrugIxazomib
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
DrugIxazomib
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
DrugIbrutinib
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
DrugIbrutinib
Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
Also known as: Imbruvica

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Jan 8, 2024

Participant flow

Participant flow — Overall Study
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

Outcome measures

PrimaryPhase 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
Reported as:: Count of participants · Participants

Phase I: Dose Limiting Toxicities (DLT) Rate
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

PrimaryPhase 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
Reported as:: Count of participants · Participants

Phase II: Complete Response Rate
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

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
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

SecondaryOverall Response Rate (ORR)

ORR assessed in accordance with Lugano classification

Time frame:: Phase I: 12 months; Phase II: 12 months
Reported as:: Count of participants · Participants

Overall Response Rate (ORR)
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

SecondaryProgression-Free Survival (PFS)

PFS assessed in accordance with Lugano classification

Time frame:: Phase I & II: 48 months
Reported as:: Median · Months

Progression-Free Survival (PFS)
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)

SecondaryOverall Survival (OS)

OS assessed during clinic visit or by reaching out to patients to confirm vital status.

Time frame:: Phase I & II: 48 months
Reported as:: Median · Months

Overall Survival (OS)
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)

Adverse events

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.

Adverse event summary by group
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%)

Most frequent serious events

Showing 10 of 26

Most frequent serious events
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

Most frequent other events

Showing 10 of 40

Most frequent other events
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

Baseline characteristics

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
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
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
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)
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)
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
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
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
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.

Study locations

14 sites

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia 30912, United States
Carle Cancer Center
Urbana, Illinois 61801, United States
University of Kansas
Overland Park, Kansas 66210, United States
Washington University School of Medicine
St Louis, Missouri 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903, United States
Laura and Isaac Perlmutter Cancer Center at NYU
New York, New York 10016, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania 19104, United States
University of Virginia
Charlottesville, Virginia 22908, United States
West Virginia University
Morgantown, West Virginia 26506, United States
Gundersen Health System
La Crosse, Wisconsin 54601, United States
University of Wisconsin
Madison, Wisconsin 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226, United States
ProHealth Care
Waukesha, Wisconsin 53188, United States

References and documents

Publications

Cohen JB, Portell CA, Hamadani M, Jegede O, Diefenbach C, Fletcher C, Matasar M, Landsburg D, Mantha S, Kahl B. An Evaluation of Ibrutinib and Ixazomib in Patients With Relapsed/Refractory Mantle Cell Lymphoma: PrE0404. Clin Lymphoma Myeloma Leuk. 2026 Jul;26(7):465-473.e1. doi: 10.1016/j.clml.2026.04.025. Epub 2026 May 4. PubMed 42209393 ↗

Study documents

Study protocol · Aug 21, 2020
Statistical analysis plan · Oct 12, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data is proprietary.

Registry details

Key details

Study ID: NCT03323151
Lead sponsor: PrECOG, LLC.
Collaborators: Takeda
Responsible party: Sponsor
First posted: Oct 26, 2017
Start date: Aug 13, 2018
Primary completion: Sep 22, 2022
Completion: Sep 7, 2023
Results posted: Jan 8, 2024
Last update: Jun 25, 2026

Study contacts

Jonathon B Cohen, MD

study chair · Emory University - Winship Cancer Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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