Actively Recruiting
Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)
Led by Ho Sup Lee · Updated on 2023-10-06
98
Participants Needed
1
Research Sites
387 weeks
Total Duration
On this page
Sponsors
H
Ho Sup Lee
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ixazomib Maintenance in Patients With Newly Diagnosed Mantle Cell Lymphoma(MCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 6919 years
- Histologically confirmed mantle cell lymphoma (MCL) with cyclin D1 expression or t(11;14) translocation
- Central laboratory confirmation of MCL diagnosis with tissue biopsy
- Stage II, III, or IV disease
- Completed 6 cycles of RCHOP or VR-CAP induction chemotherapy with at least partial response
- Not eligible for transplantation
- No clinical evidence of central nervous system involvement
- Measurable disease confirmed by CT or combined CT/PET scans within 6 weeks prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Absolute neutrophil count greater than 1,000/mm3 unless due to marrow involvement or splenomegaly
- Platelet count greater than 75,000/mm3 unless due to marrow involvement or splenomegaly
- Creatinine clearance of at least 30 mL/min
- Total bilirubin less than or equal to 1.5 times the upper limit of normal (up to 3.0 mg/dL if due to Gilbert's disease or lymphoma)
- Alanine transaminase and aspartate transaminase levels less than or equal to 3 times the upper limit of normal
- For patients over 45 years, left ventricular ejection fraction greater than 45% within 90 days prior to registration
- Female patients must be post-menopausal for at least 1 year, surgically sterile, or using effective birth control, with negative pregnancy test and agreement to continue birth control for 6 months after treatment
- Male patients must agree to use acceptable contraception during the study
You will not qualify if you...
- Female patients who are lactating or have a positive pregnancy test during screening
- Grade 2 or higher baseline peripheral neuropathy
- Major surgery within 14 days before enrollment
- Radiotherapy within 14 days before enrollment (7 days if small involved field)
- Central nervous system involvement
- Infection requiring systemic antibiotic therapy or serious infection within 14 days before enrollment
- Uncontrolled cardiovascular conditions including hypertension, arrhythmias, congestive heart failure, unstable angina, or recent myocardial infarction within 6 months
- Use of strong CYP3A inducers or St. John's wort within 14 days before first ixazomib dose
- Active systemic infection, HIV diagnosis, or active hepatitis B infection
- Serious medical or psychiatric illness interfering with treatment
- Known allergy to study medications or excipients
- Gastrointestinal disease or procedure interfering with oral ixazomib absorption or tolerance
- Diagnosis or treatment for another malignancy within 2 years prior to enrollment or residual disease from prior malignancy (nonmelanoma skin cancer or carcinoma in situ excluded if fully resected)
- More than Grade 2 peripheral neuropathy during screening
- Participation in other clinical trials with investigational agents within 30 days before or during this trial
- Previous treatment with ixazomib or participation in an ixazomib study, regardless of treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kosin University Gospel Hospital
Busan, Western, South Korea, 49267
Actively Recruiting
Research Team
H
Ho Sup Lee, MD
CONTACT
H
Hyunjung Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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