[68Ga]Ga-PentixaFor PET Imaging in CNS Lymphoma Patients

Study Purpose

This will be an open, single-arm, international, multicentre, phase II imaging study to assess the predictive value of [68Ga]Ga PentixaFor PET imaging in primary and isolated secondary central nervous system lymphoma (CNSL) patients scheduled to undergo induction chemotherapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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. 10. Life expectancy of at least 3 months, as estimated by the investigator. 11. For women of child-bearing potential: negative pregnancy test. 12. For sexually active female patients of child-bearing potential: The patient agrees to take adequate contraceptive measures during study participation and also agrees to continue use of this method for the duration of the study and for 6 months after the last dose of PTF. 13. For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception during the study and for 6 months after the last dose of PTF.

Exclusion Criteria:

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.] 9. Current toxicity of Grade >2 from previous standard or investigational therapies (grade according to the NCI Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE 5.0). 10. For female patients: Pregnancy (existing or intended) or breast-feeding. 11. Renal impairment: Both of the following: Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 Creatinine clearance < 60 ml/min. 12. Hepatic impairment: Both of the following: Aspartate aminotransferase (AST) > 3x upper limit of normal Alanine aminotransferase (ALT) > 3x upper limit of normal. 13. Presence of any unstable systemic disease (including, but not limited to, active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease. 14. Presence of psychiatric disease, alcohol abuse or any other medical condition(s) that, in the opinion of the investigator, makes the patient unable to comply with study procedures and visits. 15. Patient weight ≤ 48 kg

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05222269
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

PentixaPharm GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CNS Lymphoma
Arms & Interventions

Arms

Experimental: 68Ga-PTF

150 (+/-50) Megabecquerel (MBq) 68Ga-PTF will be injected intravenously at three timepoints during the course of the standard of care treatment.

Interventions

Drug: - 68Ga-PTF

68Ga-PTF will be injected intravenously at three time points during the course of the standard treatment of the patient.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Aalborg, Aalborg, Denmark

Status

Recruiting

Address

University Hospital Aalborg

Aalborg, , 9000

Site Contact

Majbritt Frost Nilsson

mf@rn.dk

004597665513

University Hospital CHU Nantes, Nantes, France

Status

Active, not recruiting

Address

University Hospital CHU Nantes

Nantes, , 44093

Stay Informed & Connected