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CNS LymphomaPhase 2NCT05222269

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

A Phase 2 study testing 68Ga-PTF in people with CNS Lymphoma, run by Pentixapharm AG at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
CNS Lymphoma
What is being tested?
68Ga-PTF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesin 2 countries
Study dates
5 Oct 2022to 25 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.]
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  • 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.

Who cannot join

  • 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).
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  • 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
  • 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.
  • 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.
  • Patient weight ≤ 48 kg

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • University Hospital Aalborg

    Aalborg, 9000

Other trials in Denmark

France1 site

  • University Hospital CHU Nantes

    Nantes, 44093

Other trials in France

About this study

Official title: 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

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
Being tested
68Ga-PTF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-PTFDrug

    Also called 68Ga-PentixaFor

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

Study groups in NCT05222269
Study groupRoleWhat they receive
68Ga-PTFExperimental150 (+/-50) Megabecquerel (MBq) 68Ga-PTF will be injected intravenously at three timepoints during the course of the standard of care treatment.
Receives: Drug: 68Ga-PTF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

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

    68Ga-PTF PET positivity 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 positive predictive value is defined as follows: Number of patients with tumour progression or relapse / number of patients with interim 68Ga-PTF PET assessed as CXCR4-positive by central reviewer. The proportion obtained will be multiplied by 100 to obtain a percentage value.

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

  2. Frequency and severity of AEs

    The safety will be reported by frequency, system organ class categories, and severity of adverse events (AEs). The numbers and proportions of patients with any treatment-emergent adverse event (TEAE), and any serious TEAE will be summarized.

    Measured: up to 6 months

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

    The negative predictive value (NPV) and the positive predictive value (PPV) for the prediction of PFS at the end of induction chemotherapy will be determined as described in outcome 1 and 2.

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

  4. 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)

    NPV of interim (after 6 ± 2 weeks of induction chemotherapy) 68Ga-PTF PET for the prediction of 16(±1) months CR.

    PPV of interim (after 6 ± 2 weeks of induction chemotherapy) 68Ga-PTF PET for the prediction of 16(±1) months CR.

    NPV of end-of-chemotherapy 68Ga-PTF PET for the prediction of 16(±1)-months CR.

    PPV of end-of-chemotherapy 68Ga-PTF PET for the prediction of 16(±1)-months CR.

    Response assessment will be performed 12 months after completion of induction chemotherapy and predictive values will be calculated with the results from the central visual analysis of the 68Ga-PTF PET scans at the different timepoints of induction chemotherapy.

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

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

    Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean will be determined for the pre-treatment 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

  6. Maximum tumour-to background ratio (TBRmax) and TBRmean

    Maximum tumour-to background ratio (TBRmax) and TBRmean will be determined for the pre-treatment 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

  7. Metabolic tumour volume (MTV)

    Metabolic tumour volume (MTV) will be determined for the pre-treatment 68Ga-PTF scan by relative and fixed thresholding method and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

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

    Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean will be determined for the interim 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

  9. Maximum tumour-to background ratio (TBRmax) and TBRmean

    Maximum tumour-to background ratio (TBRmax) and TBRmean will be determined for the interim 68Ga-PTF scan and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

  10. Metabolic tumour volume (MTV)

    Metabolic tumour volume (MTV) will be determined for the interim 68Ga-PTF scan by relative and fixed thresholding method and will be analyzed for their association with 16(±1)-months PFS and also with 16(±1) months CR.

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

  11. Predictive values of changes between pre-treatment and interim 68Ga-PTF PET imaging parameters for PFS

    The association of ΔSUVmax (change in SUVmax between pre-treatment 68Ga-PTF PET and interim 68Ga PTF PET) with 16(±1)-months PFS will be determined

    Measured: From visit 2 (first 68Ga-PTF PET) up to 12 months after induction chemotherapy completion

  12. Sensitivity of pre-treatment 68Ga-PTF PET for CXCR4-positivity

    In the fraction of patients from whom biopsy tissue is available, the sensitivity of the pre-treatment 68Ga-PTF PET to detect CXCR4 overexpression by immunohistochemistry (IHC) will be determined centrally on a patient basis

    Measured: up to 12 months after induction chemotherapy completion

  13. Concordance in the classification as CNSL-suspect ('yes'/'no') by 68Ga-PTF PET and MRI at baseline, on a patient level

    Diagnostic agreement between 68Ga-PTF PET and MRI at baseline imaging (after 6 +/-2 weeks of induction chemotherapy) will be determined on a patient level by evaluation of the concordance in the classification as CNSL-suspect ('yes'/'no') by 68Ga-PTF PET and MRI at baseline.

    Measured: after Visit 4 (after 6 +/-2 weeks of induction chemotherapy)

  14. Comparison of lesion numbers categorised as CNSL-suspect by 68Ga-PTF PET and MRI at baseline

    Diagnostic agreement between 68Ga-PTF PET and MRI at baseline imaging (after 6 +/-2 weeks of induction chemotherapy) will be determined on a patient level by comparing lesion numbers categorised as CNSL-suspect by 68Ga-PTF PET and MRI at baseline

    Measured: after Visit 4 (after 6 +/-2 weeks of induction chemotherapy)

  15. Observer agreement of 68Ga-PTF PET (inter- and intra-reader agreement)

    The following will be calculated with respect to 68Ga-PTF-PET positivity:

    1. Inter-reader agreement for pre-treatment 68Ga-PTF PET
    2. Inter-reader agreement for interim 68Ga-PTF PET
    3. Inter-reader agreement for 68Ga-PTF PET after induction chemotherapy completion
    4. Intra-reader agreement for pre-treatment 68Ga-PTF PET
    5. Intra-reader agreement for interim 68Ga-PTF PET
    6. Intra-reader agreement for 68Ga-PTF PET after induction chemotherapy completion
    7. Overall inter-reader agreement
    8. Overall intra-reader agreement. The intra-reader assessment will be based on an appropriately sized sample of readings.

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start5 Oct 2022
  3. Primary completion25 Jan 2023
  4. Study completion25 Jan 2023

Why it stopped: The study was early terminated due to low patient recruitment in already activated sites and difficult approval process in some of the anticipated countries. Thus, recruitment of the planned patient numbers in a reasonable time cannot be expected.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222269
Sponsor's protocol ID
PTF202
Status last verified
May 2023
First submitted
5 Jan 2022
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 68Ga-PTF in people with CNS Lymphoma, run by Pentixapharm AG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was early terminated due to low patient recruitment in already activated sites and difficult approval process in some of the anticipated countries. Thus, recruitment of the planned patient numbers in a reasonable time cannot be expected.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Negative predictive value (NPV) of interim 68Ga-PTF-PET (after 6 ± 2 weeks of induction chemotherapy) for progression-free survival (PFS) (time frame: after 6 +/-2 weeks of induction chemotherapy (interim examination) up to 12 months after induction chemotherapy completion (end of follow-up period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05222269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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