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.
1. Induction chemotherapy 1) RCHOP: Before enrollments, patients receive comprising R-CHOP, as induction therapy, comprised rituximab (at a dose of 375 mg per square meter of body-surface area), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter), vincristine (1.4mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated granulocyte-colonly stimulating factor (G-CSF) subcutaneously (SC) on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. VR-CAP: Before enrollments, patients receive comprising VR-CAP, as induction therapy, comprised bortezomib (1.3 mg per square meter of body-surface area) administered on days 1, 4, 8, 11, rituximab (at a dose of 375 mg per square meter), cyclophosphamide (750 mg per square meter), doxorubicin (50 mg per square meter) administered on days 1, and oral prednisone (100 mg per square meter) administered on days 1 to 5. Patients also receive pegylated G-CSF SC on day 2 to day 5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. 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 MTD(Maximum Tolerated Dose) 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24 months or until progression
Kosin University Gospel Hospital
Busan, Western, South Korea
RECRUITING2-year PFS rates in adult patients with newly diagnosed Mantle Cell Lymphoma
Time frame: 2years
Complete Response (CR) achievement rates after ixazomib maintenance by Lugano classification
Time frame: an average of 2 year
Overall survival (OS) rates at 2 years
overall survival of patients with Mantle Cell Lymphoma
Time frame: 2years
Adverse events (AEs)
Adverse events will be measured by the CTCAE scale, version 4.03
Time frame: 2years
Time to relapse/progression
Time to progression is measured from the date of start of study to the date of relapse/progression
Time frame: 2years
Time to next therapy (TTNT)
Time frame: 2years
Minimal residual disease (MRD) by IgH or IgK NGS from BM, lymphoma tissue at the baseline and then peripheral blood (cell free DNA).
Time frame: Screening, 24weeks, 4weeks after end of treatment
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