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

Launched by NANTES UNIVERSITY HOSPITAL · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed or refractory acute leukemia, specifically those whose cancer cells have a marker called CXCR4. The treatment involves using a radioactive substance called [177Lu]Lu-PentixaTher, which targets these CXCR4+ cells. The goal is to find the highest dose of this treatment that can be safely given to patients while monitoring its effects. This is an early-stage trial, meaning it’s still in the testing phase, and they are planning to include 6 to 21 patients in total.

To be eligible for this trial, participants must be at least 18 years old and have a diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) with a specific percentage of leukemia cells in their bone marrow. They should have already received treatment that did not work and must not have any other treatment options available. Participants will need to meet certain health criteria and provide written consent to join the study. Throughout the trial, patients can expect to undergo regular check-ups to monitor their health and the effects of the treatment. This study is currently recruiting patients, and it’s important for those interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility 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 (Annex 6)
• • 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