UnknownPhase 2

A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma

Italy12 participantsStarted 2017-10-10

Plain-language summary

The purpose of this study is to define the objective response rates (ORR) of Lorlatinib in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.

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+ 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) and at least one ALK inhibitor; presence of measurable disease by physical examination, CT or CT-PET scan.
✓. Any prior antitumor medical treatment 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. Systemic anti-cancer therapy completed within a minimum of 5 half-lives of study entry.
✓. 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.
✕. Clinically significant cardiovascular disease (that is, active or \<3 months prior to enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II)
✕. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2: second-degree or third-degree AV block (unless paced) or any AV block with PR \>220 msec, uncontrolled atrial fibrillation of any grade, bradycardia defined as \<50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc \>470 msec, or congenital long QT syndrome.
✕. Pregnancy or breastfeeding.
✕. Use of drugs or foods that are known strong or moderate CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs that are strong CYP2C19 inhibitors; drugs that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.
✕. Prior malignancy other than basal cell carcinoma , if original diagnosis happened in the last 5 years.
✕. Patients with predisposing characteristics for acute pancreatitis according to investigator judgment (e.g. uncontrolled hyperglycemia, current gallstone disease, alcoholism).
✕. Hypertriglyceridemia ≥ grade 1.

What they're measuring

Objective Response Rate

Timeframe: 1 year

Trial details

NCT IDNCT03505554

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Silvia Mori, PhD

+390392339277 silvia.mori@unimib.it

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