OncoMatch/Clinical Trials/NCT03616782
Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)
Is NCT03616782 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ixazomib for mantle cell lymphoma.
Treatment: Ixazomib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
expression of cyclin D1 (in association with CD20 and CD5)
Required: IGH t(11;14) translocation
evidence of t(11;14) translocation (by cytogenetics, fluorescence in-situ hybridization, or polymerase chain reaction)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: RCHOP induction chemotherapy — induction
Patients who received RCHOP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation
Must have received: VR-CAP induction chemotherapy — induction
Patients who received VR-CAP induction chemotherapy for 6 cycles confirmed response as more than PR or PR after induction therapy and who are ineligible for transplantation
Cannot have received: radiation therapy
Exception: If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of the ixazomib.
Radiotherapy within 14 days before enrollment
Cannot have received: ixazomib (ixazomib)
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Lab requirements
Blood counts
ANC > 1,000 mm^3 (unless low count due to marrow involvement or splenomegaly); Platelets > 75,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
Kidney function
Creatinine clearance of ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), ALT ≤3 x ULN; AST ≤3 x ULN
Cardiac function
Patients over the age of 45 must have a left ventricular ejection fraction (LVEF) of greater than 45% documented within 90 days prior to registration
ANC > 1,000 mm^3 (unless low count due to marrow involvement or splenomegaly); Platelets > 75,000 mm^3 (unless low counts due to marrow involvement or splenomegaly); Creatinine clearance of ≥ 30 mL/min; Total bilirubin ≤ 1.5 x ULN (may be up to 3.0 mg/dL if due to Gilbert's disease or due to liver involvement by lymphoma), ALT ≤3 x ULN; AST ≤3 x ULN; Patients over the age of 45 must have a left ventricular ejection fraction (LVEF) of greater than 45% documented within 90 days prior to registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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