Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03505554
Status:
RECRUITING
Last Update Posted:
2023-08-07
First Post:
2018-04-06
Brief Title:
A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
A Phase 2 Open Label Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma Previously Treated With ALK Inhibitors CRU3
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRU3
Brief 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
Detailed Description:
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
Secondary
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 prepost 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 Objectives Primary Define the objective response rates ORR of PF-06463922 in subjects with ALK lymphomas resistant or refractory to ALK inhibitors
Secondary
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 prepost 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None