Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas
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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.
objective response rates (ORR) in subjects with ALK+ lymphomas resistant or refractory to standard cytotoxic treatment, according to RECIST 1.1 criteria. [ Time Frame: the entire duration of the study (5 years) ]
Duration ORR [ Time Frame: the entire duration of the study (5 years) ]
Secondary Outcome Measures :
Progression free survival (PFS) in ALK+ lymphoma patients treated with crizotinib, that are resistant or refractory to standard cytotoxic treatment. [ Time Frame: the entire duration of the study (5 years) ]
Number of patients with adverse events after crizotinib treatment [ Time Frame: the entire duration of the study (5 years) ]
Quality of Life (QoL) in this population of patients using the the EORTC - C30 Quality of Life questionnaire [ Time Frame: the entire duration of the study (5 years) ]
Overall survival (OS) in ALK+ lymphoma patients treated with crizotinib [ Time Frame: the entire duration of the study (5 years) ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
Total serum bilirubin 1.5 x ULN (except patients with documented Gilbert's syndrome
Creatinine ≤ 1.5 x ULN.
Adequate bone marrow function:
Absolute neutrophil count (ANC) ≥ 1000/µL
Platelets ≥ 50.000/µL
Hemoglobin ≥ 9.0 g/dL The hematological values will not be considered in case of bone marrow involvement.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their partners throughout participation in this study.
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).
Prior malignancy other than basal cell carcinoma.
Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration.