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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)

Multicenter Phase II Study of Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma

Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL) (NCT03616782) is a Phase 2 interventional studying Mantle Cell Lymphoma, sponsored by Ho Sup Lee. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

1. Induction chemotherapy 1) RCHOP(Rituximab+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone) 2) VR-CAP (Bortezomib+Rituximab+Cyclophosphamide+Doxorubicin+Prednisone) Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents. 2. Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can be escalated to 4mg by response such as partial response or MRD positive. Treatment repeats every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients are screened and sign the informed consent after completion induction chemotherapy (RCHOP or VR-CAP) with more than PR or PR confirmed. It is likely to take approximately 8 weeks in performing above procedures. Patients start maintenance therapy at least 8 weeks and also can be allowed for the extension of 4 weeks because of delayed response evaluation, recovery toxicities of chemotherapy, and official process including agree with informed consent. Recently, ongoing studies about maintenance therapy in lymphoma have window periods of 8-12 weeks. Ixazomib maintenance should continue for 2 years.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Mantle Cell Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 98 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Mantle Cell Lymphoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female patients aged ≥19 years 2. diagnosed by tissue sample (biopsy-confirmed) mantle cell lymphoma (MCL) meeting the following criteria: determined by histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction) 3. In all patients, a paraffin-embedded biopsy tissue block or slides (preferably of lymph node origin or bone marrow) was sent to central laboratories (Diagnostic Cytology Laboratories or department of pathology) for confirmation of diagnosis of MCL. 4. Stage II, III, or IV 5. Patients who received RCHOP or VR-CAP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation. . 6. No clinical evidence of central nervous system (CNS) involvement by lymphoma 7. Patients must have measurable disease; CT scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined CT/PET scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the CT component 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 9. Absolute neutrophil count (ANC) \> 1,000 mm\^3 (unless low count due to marrow involvement or splenomegaly) 10. Platelets \> 75,000 mm\^3 (unless low counts due to marrow involvement or splenomegaly) 11. Creatinine clearance of ≥ 30 mL/min 12. Total bilirubin ≤ 1.5 x the upper limit of normal (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), alanine transaminase level ≤3 times the upper limit of normal; aspartate transaminase level ≤3 times the upper limit of normal 13. Patients over the age of 45 must have a left ventricular ejection fraction (LVEF) of greater than 45% documented within 90 days prior to registration ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male or female patients aged ≥19 years 2. Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: determined by histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction) 3. In all patients, a paraffin-embedded biopsy tissue block or slides (preferably of lymph node origin or bone marrow) was sent to central laboratories (Diagnostic Cytology Laboratories or department of pathology) for confirmation of diagnosis of MCL. 4. Stage II, III, or IV 5. Patients who received RCHOP or VR-CAP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation. . 6. No clinical evidence of central nervous system (CNS) involvement by lymphoma 7. Patients must have measurable disease; CT scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined CT/PET scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the CT component 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 9. Absolute neutrophil count (ANC) \> 1,000 mm\^3 (unless low count due to marrow involvement or splenomegaly) 10. Platelets \> 75,000 mm\^3 (unless low counts due to marrow involvement or splenomegaly) 11. Creatinine clearance of ≥ 30 mL/min 12. Total bilirubin ≤ 1.5 x the upper limit of normal (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), alanine transaminase level ≤3 times the upper limit of normal; aspartate transaminase level ≤3 times the upper limit of normal 13. Patients over the age of 45 must have a left ventricular ejection fraction (LVEF) of greater than 45% documented within 90 days prior to registration 14. Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study. Exclusion Criteria: 1. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 2. Grade 2 or higher baseline peripheral neuropathy 3. Major surgery within 14 days before enrollment. 4. Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib. 5. Central nervous system involvement. 6. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. 7. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. 8. Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort. 9. Active systemic infection requiring treatment, a known diagnosis of human HIV, or active hepatitis B (hepatitis B carriers were permitted) 10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 11. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 12. Known gastrointestinal(GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing. 13. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. 14. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period. 15. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial. 16. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.

Treatments Being Tested

DRUG

Ixazomib

Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24 months or until progression

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Kosin University Gospel Hospital
Busan, Western, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03616782), the sponsor (Ho Sup Lee), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03616782 clinical trial studying?

1. Induction chemotherapy 1) RCHOP(Rituximab+Cyclophosphamide+Doxorubicin+Vincristine+Prednisone) 2) VR-CAP (Bortezomib+Rituximab+Cyclophosphamide+Doxorubicin+Prednisone) Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PR(Partial response) or PR will be eligible for this study after receiving informed consents. 2. Experimental step Maintenance ixazomib beginning at least 8 weeks after completion of induction chemotherapy, patients receive ixazomib per oral 3 mg on day 1, 8, and 15 for 4 weeks. And the dose of ixazomib can b… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03616782?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03616782?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03616782. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03616782. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.