Investigating the role of innate CD8+ T cells in leukemia resistance to treatment
Search for an Association Between the Innate CD8+ T Cell Population and the Evolution of TKI (Tyrosine Kinase Inhibitor) Resistance Mutations in Phi+ Hematological Malignancies.
This study is trying to see if higher levels of certain immune cells in people with leukemia can help them resist treatment and how that relates to their cancer's ability to develop resistance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | imatinib, dasatinib, nilotinib, bosutinib, ponatinib, immunotherapy |
| Locations | 1 site (Nîmes, Gard) |
| Trial ID | NCT04965649 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between innate CD8+ T cell levels and the development of resistance mutations in patients with Philadelphia chromosome-positive hematological malignancies, specifically Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia. Researchers will assess whether low levels of BcrAbl1, despite the presence of resistance mutations, correlate with high levels of these immune cells, hypothesizing their potential anti-tumor role. The study will involve phenotyping total and innate CD8+ T cells using flow cytometry to gather data on their association with treatment resistance. The findings could provide insights into the mechanisms of resistance and inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include adult patients over 18 years with Chronic Myeloid Leukemia or Philadelphia-positive Acute Lymphoblastic Leukemia who have TKI resistance mutations.
Not a fit: Patients in the blast crisis stage of their disease or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of treatment resistance in leukemia, potentially guiding more effective therapies.
How similar studies have performed: While the specific approach of this study is novel, similar studies have explored the role of immune cells in cancer resistance, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic Myeloid Leukemia or Phi+ ALL patients with TKI resistance mutations being monitored by the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital. * Pathology resulting from a BcrAbl1 fusion gene (CML or Phi+ ALL) and presence of a TKI resistance mutation. * Patients affiliated to or beneficiaries of a health insurance scheme. * Adult patients over18 years of age. Exclusion Criteria: * Blast crisis stage pathology (according to WHO 2017 criteria (Table2.01, p33, WHO classification of tumours of haematopoietic and lymphoid tissues, IARC 2017). * Patients Under 18 years of age
Where this trial is running
Nîmes, Gard
- CHU de Nîmes — Nîmes, Gard, France (Recruiting)
Study contacts
- Study coordinator: Serge CARILLO, PharmD, PhD
- Email: serge.carillo@chu-nimes.fr
- Phone: +33 466 68 34 00
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.