RecruitingPhase 2NCT03616782

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


Sponsor

Ho Sup Lee

Enrollment

98 participants

Start Date

Dec 24, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a drug called ixazomib (taken as a pill) can be used as maintenance therapy — a long-term low-dose treatment to prevent cancer from coming back — in patients with a type of lymphoma called mantle cell lymphoma who responded well to their initial chemotherapy. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with mantle cell lymphoma (MCL), confirmed by biopsy - Your cancer is at stage II, III, or IV - You have already completed initial chemotherapy (RCHOP or VR-CAP) and responded well to it **You may NOT be eligible if...** - Your cancer did not respond to initial chemotherapy - You are at stage I of mantle cell lymphoma - You are pregnant or breastfeeding - You have serious liver or kidney problems - You have significant nerve damage (peripheral neuropathy) from prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIxazomib

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


Locations(1)

Kosin University Gospel Hospital

Busan, Western, South Korea

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NCT03616782


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