Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas (NCT02419287) | Clinical Trial Compass
CompletedPhase 2
Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas
Italy12 participantsStarted 2015-04
Plain-language summary
The purpose of this study is to determine the response and the duration of it in patients affected by ALK+ lymphoma that are resistant or refractory to standard cytotoxic treatment that will be treated with crizotinib.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.
. ALK+ Non-Hodgkin lymphoma diagnosed by IHC or FISH.
. Refractory disease or relapse after at least one prior chemotherapy regimen (typically a minimum of 6 cycles of CHOP); presence of measurable disease by physical examination, CT or CT-PET scan.
. Any prior chemotherapy or major surgeries must have been completed at least 14 days prior to initiation of study medication. This could not be respected if there is clear evidence of disease progression, manifested as growing pain attributable to the tumour, fever, growing tumour lesions, increasing LDH values.
. Able to take oral therapy.
. Female or male, 18 years of age or older.
. ECOG performance status 0-3.
. Adequate organ function as defined by the following criteria:
Exclusion criteria
. Current treatment on another therapeutic clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
objective response rates (ORR) in subjects with ALK+ lymphomas resistant or refractory to standard cytotoxic treatment, according to RECIST 1.1 criteria.
Timeframe: the entire duration of the study (5 years)
2
Duration ORR
Timeframe: the entire duration of the study (5 years)
. Prior therapy specifically directed against ALK.
. Major surgery within 14 days prior first dose of crizotinib.
. History of uncontrolled cardiac disease including: myocardial infarct, uncontrolled angina or hypertension, clinically significant ventricular arrhythmia, unexplained syncope.
. Pregnancy or breastfeeding.
. Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to amprenavir, atazanavir, clarithromycin, delavirdine, diltiazem, erythromycin, indinavir, itraconazole, ketoconazole, miconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil, voriconazole, and grapefruit or grapefruit juice.
. Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, tipranavir, ritonavir, and St. John's wort.
. Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited aripiprazole, ergotamine, halofantrine, pimozide, triazolam, astemizole\*, cisapride\*, and terfenadine\* (\* withdrawn from U.S. market).