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Acute LeukemiaPhase 1/2PENTILULANCT06356922

Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.

A Phase 1/2 study testing Experimental drug [177Lu]Lu-PentixaTher in people with Acute Leukemia, run by Nantes University Hospital at 4 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Acute Leukemia
What is being tested?
Experimental drug [177Lu]Lu-PentixaTher
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesFrance
Study dates
22 Oct 2024to 22 Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • AML/ALL (OMS) with >5% of blasts in bone marrow (with or without extramedullary localisation)
  • CXCR4+ (ratio >2/isotypic control) at the time of pre-inclusion
  • All previously treated AML/ALL patients who have experienced relapse or treatment failure with no alternative treatment
  • At least 15 days since previous treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
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  • eGFR ≥ 50 ml/min by MDRD or CKDEPI
  • ASAT or ALAT > 5 upper normal value (except in case of documented presence of leukemia in the liver)
  • Serum bilirubin ≤ 30 µmol/l
  • Negative pregnancy test documented prior to enrolment (for females of childbearing potential)
  • Agree to use an effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile)
  • No active cardiac dysfunction (LVEF > 45%)
  • DLCO >40%
  • Written informed consent
  • Be willing and able to comply with scheduled visits and study procedures
  • Affiliation with French social security system or beneficiary from such system

Who cannot join

  • Meningeal involvement
  • HIV positive
  • Active Hepatitis B or C
  • Active infection within 7 days of starting treatment
  • Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 1 year
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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  • Participation at the same time in another study in which investigational drugs are used
  • Patient with contra-indications to Rhu-EPO, Rhu-GCSF, allopurinol, rasburicase, anti-histamines and corticosteroids
  • Absence of written informed consent
  • Pregnant or child breast feeding woman
  • Patient under guardianship or trusteeship
  • Patient under judicial protection

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU d'Angers

    Angers, Maine et Loire, 49100

  • CHU de Bordeaux

    Bordeaux, Gironde, 33604

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Puy de Dôme, 63000

  • CHU de Nantes

    Nantes, Loire-Atlantique, 44000

Other trials in France

About this study

Official title: Phase I/II Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.

CXCR4 inhibition may represent a new therapeutic strategy in acute leukemia (AL) patients, not only by increasing chemosensitivity but also by preventing relapse of the disease by disruption of the interaction of residual leukemic cells with the bone marrow niche. Radiolabeled CXCR4 ligands have been developed for PET imaging (68Ga-PentixaFor; INN: Gallium (68Ga) boclatixafortide) and radioligand therapy (RLT) ([177Lu]Lu-PentixaTher/[90Y]Y-PentixaTher). [177Lu]Lu and [90Y]Y-PentixaTher have been tested in three multiple myeloma patients in named-patient use with a remarkable efficacy in 2 patients (Herrmann, 2016). Moreover, feasibility of CXCR4 PET imaging in AML was reported, providing a framework for future theranostic approaches targeting the CXCR4/CXCL12-defined leukemia-initiating cell niche (Herhaus, 2016).

Here a Phase I/II study to determine maximal tolerated dose (MTD) of a RLT using [177Lu]Lu-PentixaTher in relapsed/refractory AL was designed. This will be a standard phase I/II 3+3 dose escalation study. Five dose levels will be tested, so 6 to 21 patients have to be included in the study.

Conditions
Acute Leukemia
Being tested
Experimental drug [177Lu]Lu-PentixaTher

What participants receive

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

  • Experimental drug [177Lu]Lu-PentixaTherDrug

    Injection of [177Lu]Lu-PentixaTher

Study groups in NCT06356922
Study groupRoleWhat they receive
[177Lu]Lu-PentixaTherExperimentalInjection of [177Lu]Lu-PentixaTher
Receives: Drug: Experimental drug [177Lu]Lu-PentixaTher

What is being measured

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

  1. Safety of RLT using one injection of [177Lu]Lu-PentixaTher

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Between Week 4 and Week 6

  2. Tolerance

    Tolerance of the RLT will be evaluated by dosimetry studies, especially in terms of renal and hepatic doses delivered

    Measured: Between Week 4 and Week 6

Secondary outcomes (14)

  1. Overall response rate

    Response evaluation (CR, CRp and PR) after the infusion of [177Lu]Lu-PentixaTher

    Measured: Between Week 4 and Week 6

  2. Complete response rate

    Response evaluation (CR, CRp) after the infusion of [177Lu]Lu-PentixaTher

    Measured: Between Week 4 and Week 6

  3. Overall survival

    Time interval from the date from initial of study treatment (D0) until the date of last follow-up or death

    Measured: Month 12

  4. Leukemia-free survival

    Time interval from the date of documented complete response (CR, CRp) until the date of last follow-up, death or relapse

    Measured: Month 12

  5. Minimal residual disease

    CXCR4 ratio by flow cytometry after [177Lu]Lu-PentixaTher

    Measured: Month 12

  6. Whole-body biodistribution

    Serial whole body scintigraphies

    Measured: Between Week 4 and Week 6

  7. Plasma uptake

    The activity in each plasma sample will be determined by counting 0,2 ml of plasma in a calibrated gamma counter with an appropriate window setting. The maximal uptake (%) and area under the curve (AUC) of [ 177Lu]Lu-PentixaTher at the target lesion, organs and blood will be determined

    Measured: Between Week 4 and Week 6

  8. Radiation dosimetry

    Whole body quantitative scintigraphies

    Measured: Between Week 4 and Week 6

  9. Renal safety

    Renal safety will be assessed by measuring creatinine

    Measured: Month 12

  10. Renal safety

    Renal safety will be assessed by measuring urea

    Measured: Month 12

  11. Renal safety

    Renal safety will be assessed by measuring eGFR by MDRD or CKDEPI

    Measured: Month 12

  12. Correlation between different cytokines and toxicity

    FLT3 and IL6 serum level

    Measured: Month 12

  13. Factors associated response

    Responses will be evaluated 4/6 weeks after the infusion of [177Lu]Lu-PentixaTher (Day 0): Complete remission (CR) is defined by normalization of the blood and the bone marrow with < or = 5% of blasts, neutrophil count > 1.109 /l and platelet count >100 Giga/l. CR with incomplete platelets recovery (CRp) is defined as for CR including platelet transfusion independence but with platelet count remaining below 100 Giga/l. Partial response (PR) is defined by blast clearance ≥50% in blood or bone marrow or bone marrow with > 5% and < 20 % of blasts

    Measured: Month 12

  14. Exploratory outcome measure = Identification of biological biomarkers

    Different cytokines including FLT3 and IL6 serum levels will be monitored by serial blood sampling at D1, D8, D15, D22 as well as during the monitoring visits at 1 month, and only FLT3 and IL6 at 3, 6, 9 and 12 months

    Measured: Month 12

Timeline

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

  1. First posted10 Apr 2024
  2. Study start22 Oct 2024
  3. Primary completion22 Oct 2027 (estimated)
  4. Study completion22 Oct 2027 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356922
Sponsor's protocol ID
RC20_0123
Acronym
PENTILULA
Status last verified
Jul 2026
First submitted
22 Mar 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Experimental drug [177Lu]Lu-PentixaTher in people with Acute Leukemia, run by Nantes University Hospital at 4 sites in France.

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 16 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Safety of RLT using one injection of [177Lu]Lu-PentixaTher (time frame: Between Week 4 and Week 6). The study lists 2 primary outcomes in all. 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 NCT06356922.

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 29 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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