A prospective, international, multi-centre, open-label,single-arm phase II study investigating the predictive value of [68Ga]Ga-PentixaFor PET imaging in primary and isolated secondary CNS lymphoma patients - [68Ga]Ga-PentixaFor PET imaging in CNS lymphoma patients

PentixaPharm GmbH0 sites50 target enrollmentApril 2, 2022

ConditionsCentral nervous system (CNS) lymphoma MedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Central nervous system (CNS) lymphoma
Sponsor: PentixaPharm GmbH
Enrollment: 50
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 2, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

PentixaPharm GmbH

Eligibility Criteria

Inclusion Criteria

•All study patients must meet all the following criteria:
•1\.Written informed consent obtained according to international guidelines and local laws by patient (or legally acceptable representative if the patient is temporarily legally not competent owing to his/her disease). \[Note: No invasive study\-specific procedures may be carried out until this consent has been given.]
•2\.Patient aged 18 years or above (either sex).
•3\.Histologically confirmed primary or secondary CNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy.
•4\.Disease exclusively located in the CNS (primary CNSL or secondary CNSL with isolated CNS relapse). Subjects who had undergone allogeneic stem cell transplant \> 12 months prior to first dose of study drug, have no evidence of active graft versus host disease, and are not on systemic immunosuppressive therapy are allowed to participate in the study.
•5\.At least one measurable parenchymal lesion. \[Note: parenchymal CNSL is a must”, and additional locations such as leptomeningeal disease are permitted.]
•6\.Previously untreated CNS disease.\[Note: Previous or ongoing steroid treatment is permitted. Prophylaxis chemotherapy is not necessary, as induction chemotherapy will start within 72 hours after PTF\-PET.]
•7\.At least one morphologically measurable lesion according to the IPCG criteria (Appendix 1\).
•8\.Patients scheduled to undergo induction chemotherapy based on one of the following: High\-dose methotrexate (HD\-MTX)\-based chemotherapy, ICE/DeVIC or High\-dose cytarabine (HD\-AraC)\-based chemotherapy.
•9\.ECOG performance status \= 2 for patients aged \=65 years;ECOG performance status \= 3 for patients aged \<65 years.

Exclusion Criteria

•Any patient meeting one or more of the following criteria will not be included:
•1\.Known hypersensitivity to \[68Ga]Ga\-PentixaFor or its components.
•2\.Contraindication for contrast\-enhanced MRI as set out in the relevant institutional guidelines (e.g., pacemaker, defibrillator, aneurysm clip, metal in the body, renal insufficiency, severe claustrophobia etc.).
•3\.Contraindication for the use of gadolinium contrast for MRI.
•4\.Contraindication for PET according to institutional guidelines (weight\-based, e.g. weight \> 180 kg).
•5\.Inability to lie still for the entire imaging time.
•6\.Systemic lymphoma manifestation (outside the CNS).
•7\.Presence of active infection at screening or history of serious infection within the previous 6 weeks (except HIV infection: patients with HIV\-associated primary CNSL are considered eligible).
•8\.Administration of another investigational medicinal product within the 30 days (or 5 excretion half\-lives, whichever period is the longer) before first treatment with PTF.
•\[Note: Re screening may be performed to accept washout of prior agents.]