A pivotal phase 3 clinical trial to assess the diagnostic performance and safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a positron emission tomography (PET) imaging agent, versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma (MZL) exemplary for CXCR4-positive malignant lymphomas: a prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial (LYMFOR).

Pentixapharm AG20 sites in 5 countries148 target enrollmentNovember 29, 2023

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Pentixapharm AG
Enrollment: 148
Locations: 20
Primary Endpoint: 1. Superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by SoT (central histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation of clinical and imaging follow-up). (Refer to Protocol for complete information)
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by a Standard of Truth (SoT; centrally histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation clinical and imaging follow-up).

Registry

euclinicaltrials.eu

Start Date

November 29, 2023

End Date

TBD

Last Updated

11 months ago

Investigators

Sponsor

Pentixapharm AG

Responsible Party

Principal Investigator

Clinical trial team

Scientific

Pentixapharm GmbH

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form (ICF) from the patient
•Patients of either gender, aged ≥ 18 years
•Patients with a histologically proven diagnosis of MZL according to the 4th revised edition of the World Health Organization HAEM4R classification of lymphoid neoplasms as well as established MZL stage. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown). The biopsy used for MZL diagnosis (diagnostic biopsy) must not be collected more than 12 weeks before Visit
•Treatment-naïve
•Negative pregnancy test in women capable of child-bearing and their agreement to use highly effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG
•For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception for 1 month after the last dose of [68Ga]Ga-PTF and [18F]FDG
•Acceptable organ function (refer to Protocol for complete information)
•Life expectancy ≥ 12 weeks as estimated by the Investigator
•The patient must not have undergone any physical or pharmacological intervention with curative or palliative intent between the time of any of the diagnostic measures and the [68Ga]Ga-PTF PET/CT and [18F]FDG PET/CT scan

Exclusion Criteria

•Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product
•Current greater than grade 2 toxicity from any reason, per US-NCI "Common Terminology Criteria for Adverse Events v5.0" (NCI CTCAE 2017) except if tumor-related
•Pregnant or breast-feeding women.
•Colony-stimulating factor (CSF) therapy within 5 days prior to [18F]FDG PET/CT examination.
•Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening.
•Concomitant prohibited treatment which may interfere with [68Ga]Ga-PTF PET/CT imaging (systemic corticosteroids) administered within the last 1 month prior to study start
•Judged by the referring physician as not mentally or as not physically fit to understand and comply with protocol-related interventions and procedures (e.g., medically retarded, body weight > 180 kg for PET scanner)
•Body weight of less than 48 kg
•Inability to lie still for the entire imaging time
•Any severe acute or active chronic infection, as judged by the Investigator, at the time of screening or within two months prior to screening that may interfere with the diagnostic properties of [68Ga]Ga-PTF PET/CT or [18F]FDG PET/CT imaging

Outcomes

Primary Outcomes

1. Superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by SoT (central histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation of clinical and imaging follow-up). (Refer to Protocol for complete information)

Secondary Outcomes

3. Assessment of the impact on staging of each PET/CT imaging agent.
4. Assessment of the impact on the intended treatment plan and patient management of each PET/CT imaging agent.
2. Central assessment of the impact on staging of each PET/CT imaging agent.
5. Assessment of the percentage of inter-observer agreement of each PET/CT imaging agent local vs. central in terms of staging.
6. Local and central assessment of the impact on staging of each PET/CT imaging agent and stratification in MZL subtypes.
7. Local and central assessment of the impact on the intended treatment plan and patient management of each PET/CT imaging agent and stratification in MZL subtypes.
8. Central assessment of diagnostic performance, consisting of sensitivity and specificity of each PET/CT imaging agent in tumor detection on a region-basis confirmed by SoT.
9. Assessment of sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT.
10. Assessment of diagnostic accuracy of each PET/CT imaging agent to detect tumor lesions on a per patient-basis and lesion-basis confirmed by SoT.
11. Determination of PPV and NPV of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis.
12. Tumor detection rate of each PET/CT imaging agent on a patient-basis and on lesion-basis confirmed by SoT or surrogate SoT.
13. Proportion of patients with additional or less lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging.
14. Assessment of the percentage of intra- and inter-reader agreement of each PET/CT imaging agent for tumor detection on a lesion-basis, region-basis and patient-basis.
15. Evaluation of reproducibility of [68Ga]Ga-PTF PET/CT imaging by comparison of two successive [68Ga]Ga-PTF PET/CT scans in a subpopulation of patients.
16. Assessment of the image quality of each PET/CT imaging agent in PET-positive lesions.
17. To evaluate the safety and tolerability of each PET/CT imaging agent.