Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03616782
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2018-07-09
Brief Title:
Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell LymphomaMCL
Sponsor:
Ho Sup Lee
Organization:
Kosin University Gospel Hospital
Study Overview
Official Title:
Multicenter Phase II Study of Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Induction chemotherapy 1 RCHOPRituximabCyclophosphamideDoxorubicinVincristinePrednisone 2 VR-CAP BortezomibRituximabCyclophosphamideDoxorubicinPrednisone
Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PRPartial 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
Patients who have received induction chemotherapy will be evaluated for responses and those who achieved more than PRPartial 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 14mg 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 13 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 PRPartial 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 MTDMaximum 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
VR-CAP Before enrollments patients receive comprising VR-CAP as induction therapy comprised bortezomib 13 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 PRPartial 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 MTDMaximum 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None