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RECRUITING
NCT03616782
PHASE2

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

Sponsor: Ho Sup Lee

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2018-12-24

Completion Date

2026-05-31

Last Updated

2023-10-06

Healthy Volunteers

No

Interventions

DRUG

Ixazomib

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