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 Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial

Status: Terminated
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
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∙ All patients must meet all of the following criteria:

• Signed informed consent from the patient.

• Patients of either gender, aged ≥ 18 years.

• Patients with a histologically proven diagnosis of marginal zone lymphoma (MZL) according to the World Health Organization (WHO) classification of lymphoid neoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown).

• 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, as evidenced by the following laboratory data:

‣ No renal impairment: Estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2or creatinine clearance \> 60 mL/min by the Cockcroft-Gault equation or equivalent

⁃ Total bilirubin ≤ 1.5 × ULN (upper limit of normal)

⁃ Serum albumin ≥ 2.5 g/dL.

⁃ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in the presence of liver metastases

⁃ International normalized ratio (INR) \< 1.3 or ≤ institutional ULN.

• 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.

Locations
Other Locations
Austria
Medizinische Universität Innsbruck
Innsbruck
France
CHU de Bordeaux
Bordeaux
CHU La Timone
Marseille
CHU de Nantes
Nantes
Hôpital Cochin
Paris
Germany
Universitätsklinikum Essen
Essen
Universitätsklinikum Würzburg
Würzburg
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
L'IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
Meldola
Ospedale San Raffaele S.r.l.
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
Spain
Clinica Universidad de Navarra
Pamplona
Time Frame
Start Date: 2024-05-20
Completion Date: 2025-07-18
Participants
Target number of participants: 13
Treatments
Experimental: [68Ga]Ga-PTF PET/CT
150 (+/-50) MBq \[68Ga\]Ga-PTF will be administered intravenously and PET/CT will be performed
Active_comparator: [18F]FDG PET/CT
\[18F\]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed
Related Therapeutic Areas
Sponsors
Collaborators: Pivotal S.L.
Leads: Pentixapharm AG

This content was sourced from clinicaltrials.gov