Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.