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 range18 Years

SexALL

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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.
✕. 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).

What they're measuring

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)

Duration ORR

Timeframe: the entire duration of the study (5 years)

Trial details

NCT IDNCT02419287

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Anaplastic Large Cell Lymphoma, ALK-Positive trials