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Aurora Kinase Inhibitor
Triple Therapy for Lymphoma
Phase 1
Waitlist Available
Led By Catherine S Diefenbach
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (obtained within 30 days of registration)
Patients must have histologically confirmed relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma (NHL); patients with evidence of transformation to a high grade histology will not be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 8 (course 1)
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs, alisertib and bortezomib, when given together with rituximab to treat patients with mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory).
Who is the study for?
This trial is for adults with relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma. Participants must have adequate organ function, no high-grade cancer transformation, and agree to use contraception. They should not have had certain treatments recently and must be able to take oral medication.Check my eligibility
What is being tested?
The trial tests the combination of alisertib and bortezomib with rituximab to find the best dose and side effects profile in treating specific types of lymphoma that are resistant or have returned after treatment. It aims to see if this combo can better inhibit cancer cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system interference by rituximab, as well as possible organ inflammation, fatigue, digestive issues from alisertib and bortezomib. Side effects vary based on individual tolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
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My lymphoma has come back or hasn't responded to treatment, but it hasn't become more aggressive.
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I have HIV but no AIDS, a low viral load, and not on certain HIV meds.
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I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 8 (course 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 8 (course 1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose of alisertib when combined with bortezomib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT)
Recommended phase II dose of bortezomib when combined with alisertib and rituximab, defined as the highest dose level at which < 33% of the dose cohort experience a dose limiting toxicity (DLT)
Secondary outcome measures
Duration of response (DOR)
Overall response rate (ORR) (complete response and partial response)
Overall survival
+1 moreOther outcome measures
Aurora A expression measured from patient biopsy specimens
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (alisertib, bortezomib, and rituximab)Experimental Treatment4 Interventions
Patients receive alisertib PO BID on days 1-7; bortezomib SC on days 1, 8, and 15; and rituximab IV on day 1. Treatment repeats every 28 days* in the absence of disease progression or unacceptable toxicity.
Note: *After 8 courses, treatment with rituximab repeats once every 3 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Alisertib
2010
Completed Phase 2
~1140
Bortezomib
2005
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,129 Total Patients Enrolled
Catherine S DiefenbachPrincipal InvestigatorMontefiore Medical Center - Moses Campus
3 Previous Clinical Trials
236 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had allergic reactions to medications similar to MLN8237, bortezomib, or rituximab.My lymphoma can be measured or evaluated and I've had the necessary scans and tests recently.You are not currently taking any other experimental medications.I am not taking pancreatic enzymes while on this study.I am currently on bisphosphonate therapy and started it before joining the study.My kidney function, measured by creatinine levels or clearance, is within the normal range.I agree not to drive or use dangerous tools if I feel overly sleepy from MLN8237 treatment.I can limit my alcohol to one drink a day and minimize CNS-affecting drugs during the study.My lymphoma has come back or hasn't responded to treatment, but it hasn't become more aggressive.I have HIV but no AIDS, a low viral load, and not on certain HIV meds.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or 6 weeks for specific drugs, and have recovered from any side effects.I do not have brain metastases.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I've had chemotherapy for my condition, possibly with rituximab or a stem cell transplant, but haven't had bortezomib in the last 6 months.I have conditions like severe sleep apnea or COPD that cause extreme daytime sleepiness.I cannot swallow pills or follow the required fasting for medication.I am HIV-positive but not on certain HIV medications, and my CD4 count is above 300.I am not taking any drugs that are not allowed with MLN8237.I do not take antacids 2 hours before or after my MLN8237 dose.I am not taking certain seizure medications, rifampin, or St. John's wort.I can take care of myself but may not be able to do heavy physical work.I use benzodiazepines, but I can try to stop if needed.I have stopped using proton pump inhibitors for at least 4 days.I am not taking H2 blockers, except as premedication for rituximab.I am not pregnant and will stop breastfeeding to participate.I can take pills and fast for 3 hours around taking my medication.I experience significant numbness or pain in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (alisertib, bortezomib, and rituximab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this medical experiment currently available?
"This clinical trial is no longer enrolling. It was initially posted on August 31st 2012 and had its most recent update on July 27th 2022. If you are looking for further research, there are currently 2664 studies involving diffuse lymphoma recruiting patients as well as 538 trials investigating Rituximab actively seeking participants."
Answered by AI
What is the current sample size of participants in this clinical trial?
"Unfortunately, this trial is closed to new participants at the time of writing. It was initially posted on August 31st 2012 and upgraded last July 27th 2022. If you are searching for alternative studies, 2664 trials related to lymphoma diffuse are actively enrolling patients as well as 538 with Rituximab therapies."
Answered by AI
What illnesses does Rituximab have the most success in alleviating?
"Rituximab is commonly prescribed to treat conditions such as DLBCL, B-cell lymphomas, polyangium and pemphigus vulgaris."
Answered by AI
To what extent could Rituximab put patients at risk?
"Rituximab's safety has been minimally evaluated in the clinical setting, thus it was given a score of 1."
Answered by AI
Are there any precedents for using Rituximab in clinical trials?
"The first clinical trial assessing the efficacy of Rituximab occured in 1993 at National Institutes of Health Clinical Center. Since then, there have been 1721 completed trials and 538 ongoing studies scattered across the United States; many located within Bronx, Pennsylvania."
Answered by AI
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