Assessing a new treatment for relapsed acute leukemia using a radiolabeled drug.
Phase I/II Study Assessing Radioligand Therapy (RLT) Using [177Lu]Lu-PentixaTher for Relapsed/Refractory CXCR4+ Acute Leukemia.
This study is testing a new radiolabeled drug to see if it can help adults with relapsed acute leukemia feel better and prevent their cancer from coming back.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 4 sites (Bordeaux, Gironde and 3 other locations) |
| Trial ID | NCT06356922 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a radioligand therapy using [177Lu]Lu-PentixaTher for patients with relapsed or refractory acute leukemia who express the CXCR4 marker. The trial aims to determine the maximum tolerated dose of this experimental treatment while also exploring its potential to enhance chemosensitivity and prevent disease relapse. Participants will be closely monitored for their response to the therapy and any adverse effects. The study is designed for adults who have exhausted other treatment options and have a specific level of leukemia cells in their bone marrow.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory acute leukemia and a significant presence of CXCR4+ cells.
Not a fit: Patients with active cardiac dysfunction or those who have not previously received treatment for their leukemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat acute leukemia.
How similar studies have performed: Previous studies have shown promising results with similar approaches in other hematological malignancies, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Bordeaux, Gironde and 3 other locations
- CHU de Bordeaux — Bordeaux, Gironde, France (Recruiting)
- CHU de Nantes — Nantes, Loire-Atlantique, France (Recruiting)
- CHU d'Angers — Angers, Maine et Loire, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, Puy de Dôme, France (Recruiting)
Study contacts
- Study coordinator: Patrice CHEVALLIER
- Email: patrice.chevallier@chu-nantes.fr
- Phone: 02 40 08 39 94
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.