A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma (CRU3)
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|ClinicalTrials.gov Identifier: NCT03505554|
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Large Cell Lymphoma, ALK-Positive||Drug: Lorlatinib||Phase 2|
Lorlatinib is a selective and potent tyrosine kinase inhibitor of ALK and ROS1 that pre-clinically demonstrated dose-dependent inhibition of mutations that confer resistance to other ALK inhibitors; it is also a brain-penetrant thus it might be active in patients with CNS metastases.
Study Objectives Primary Define the objective response rates (ORR) of PF-06463922 in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.
- Define the Progression Free Survival (PFS) in subjects with ALK+ lymphomas resistant or refractory to ALK inhibitors.
- Define the overall survival (OS) in ALK+ lymphoma patients treated with Lorlatinib, that are resistant or refractory to ALK inhibitors.
- Determine the toxicity profile of Lorlatinib in ALK+ lymphoma patients resistant or refractory to ALK inhibitors.
- Determine the Quality of Life (QoL) in this population of patients using the EORTC-C30 Quality of Life questionnaire.
- Study the mutational status of ALK pre/post Lorlatinib treatment through next-generation sequencing (NGS).
Study design This is a phase 2 study open to 12 eligible patients with lymphoma with a confirmed ALK rearrangement. All patients must have been pretreated with at least one line of standard cytotoxic chemotherapy and at least one ALK inhibitor and they must have demonstrated progression (regardless of initial response) or resistance on the last treatment.
The study begins with a screening period to assess eligibility, up to and including 28 days prior to the first dose of Lorlatinib. Treatment will continue until patient experiences unacceptable toxicity or progressive disease (PD), starts a new anti-cancer therapy or dies.
The study will remain open until all patients have completed 3 years from the enrollment.
Study treatment Patients will receive an oral administration of Lorlatinib at a dose of 100mg QD. In case of toxicity, it is possible to proceed to a dose reduction (75mg or 50mg QD) or a temporary interruption of Lorlatinib.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors (CRU3)|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
100 mg QD
100 mg QD
Other Name: PF-06463922
- Objective Response Rate [ Time Frame: 1 year ]ORR
- Progression Free Survival [ Time Frame: 1 year ]PFS
- Overall Survival [ Time Frame: 1 year ]OS
- toxicity [ Time Frame: up to 24 months ]number, type and grade of adverse events
- Quality of life [ Time Frame: up to 24 months ]Use of EORTC-QLQ-C30 questionnaire
- Study the mutational status of ALK pre/post Lorlatinib [ Time Frame: up to 24 months ]Mutational Analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505554
|Contact: Silvia Mori, PhDemail@example.com|
|Contact: Silvia Baretta, SCfirstname.lastname@example.org|
|Monza, Italy/MB, Italy, 20900|
|Contact: Carlo Gambacorti-Passerini, MD +390392339553 email@example.com|
|Principal Investigator: Carlo Gambacorti-Passerini, MD|
|Principal Investigator:||CARLO GAMBACORTI-PASSERINI, MD||University of Milano Bicocca|