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

NCT05222269 | Terminated Phase 2

• 1 other identifier: PTF202
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

CNS Lymphoma

Outcome Measures

Primary Outcomes (1)

• Negative predictive value (NPV) of interim 68Ga-PTF-PET (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS)

  68Ga-PTF PET negativity for CXCR4 will be determined by visual analysis in central reading. For PFS assessment (yes/no variable), tumour progression or relapse will be determined according to the IPCG response criteria (Abrey et al. 2005) for the time period starting at baseline and ending at approx. 12 months after induction chemotherapy completion. The negative predictive value is defined as follows: Number of patients without tumour progression or relapse / number of patients with interim 68Ga-PTF PET assessed as CXCR4-negative by central reviewer. The proportion obtained will be multiplied by 100 to obtain a percentage value. This NPV will be calculated for the entire study population and also stratified by induction chemotherapy regimen (HD-MTX-based, DeVIC/ICE, HD-AraC-based regimen).

  after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period)

Secondary Outcomes (15)

• Positive predictive value (PPV) of interim 68Ga-PTF PET (after 6 ± 2 weeks of induction chemotherapy) for PFS

  after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period)

• Frequency and severity of AEs

  up to 6 months

• Predictive values of 68Ga-PTF PET at the end of induction chemotherapy for PFS

  end of induction chemotherapy up to 12 months after induction chemotherapy completion

• Predictive values of 68Ga-PTF PET at interim examination (after 6 ± 2 weeks of induction chemotherapy) and end-of-chemotherapy-treatment for complete response (CR)

  after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period)

• Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean

  after pretreatment examination up to 12 months after induction chemotherapy completion (end of follow-up period)

Study Arms (1)

68Ga-PTF

EXPERIMENTAL

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

Drug: 68Ga-PTF

Interventions

68Ga-PTF DRUG

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

Also known as: 68Ga-PentixaFor

68Ga-PTF

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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). \[Note: No invasive study-specific procedures may be carried out until this consent has been given.\]
• Patient aged 18 years or above (either sex).
• Histologically confirmed primary or secondary CNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy.
• 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.
• At least one measurable parenchymal lesion. \[Note: parenchymal CNSL is a "must", and additional locations such as leptomeningeal disease are permitted.\]
• Previously untreated CNS disease. \[Note: Previous or ongoing steroid treatment is permitted. Prophylaxis chemotherapy is not necessary, as induction chemotherapy will start within 72 hours after PTF-PET.\]
• At least one morphologically measurable lesion according to the IPCG criteria (Appendix 1).
• 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.
• ECOG performance status ≤ 2 for patients aged ≥65 years; ECOG performance status ≤ 3 for patients aged \<65 years.
• Life expectancy of at least 3 months, as estimated by the investigator.
• For women of child-bearing potential: negative pregnancy test.
• 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.
• 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.

You may not qualify if:

• Known hypersensitivity to \[68Ga\]Ga-PentixaFor or its components.
• 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.).
• Contraindication for the use of gadolinium contrast for MRI.
• Contraindication for PET according to institutional guidelines (weight-based, e.g. weight \> 180 kg).
• Inability to lie still for the entire imaging time.
• Systemic lymphoma manifestation (outside the CNS).
• 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).
• 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.
• \[Note: Re screening may be performed to accept washout of prior agents.\]
• 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).
• For female patients: Pregnancy (existing or intended) or breast-feeding.
• Renal impairment: Both of the following:
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2 Creatinine clearance \< 60 ml/min
• Hepatic impairment: Both of the following:
• Aspartate aminotransferase (AST) \> 3x upper limit of normal Alanine aminotransferase (ALT) \> 3x upper limit of normal

Sponsors & Collaborators

• Pentixapharm AG: lead

Study Sites (2)

University Hospital Aalborg

Aalborg, 9000, Denmark

Location

University Hospital CHU Nantes

Nantes, 44093, France

Location

MeSH Terms

Interventions

68Ga-pentixafor

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 3, 2022
• Study Start: October 5, 2022
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: September 5, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DK (1)