NCT03616782

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Ho Sup Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Mantle Cell Lymphoma

Interventions

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

Timeline

• Start date: 2018-12-24
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2018-08-06
• Last updated: 2023-10-06

Locations

1 site across 1 country: South Korea