Leukemia Clinical Trial
— TIPHIOfficial title:
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.
The aim of this project is to test whether low levels of BcrAbl1, despite the presence of resistance mutations, are related to high levels of innate CD8+ T cells, in the hypothesis that these cells have an anti-tumor role. This research aims to investigate: - An association between the rate of innate CD8+ T cells and the evolution of Phi+ pathologies (Chronic Myeloid Leukemia and Philadelphia chromosome-positive Acute lymphocytic leukemia (Phi+ ALL) carrying a resistance mutation, according to the ELN 2013 and Phi LMC recommendations. - An association between the level of innate CD8+ T cells and the expansion of TKI resistance clones, assessed as the number of BcrAbl1 copies carrying the mutation relative to the number of Abl1 copies.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 1, 2025 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes | Nîmes | Gard |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Cayuela JM, Chomel JC, Coiteux V, Dulucq S, Escoffre-Barbe M, Etancelin P, Etienne G, Hayette S, Millot F, Nibourel O, Nicolini FE, Rea D; pour la France Intergroupe des leucemies myeloides chroniques (Fi-LMC) et le Groupe des biologistes moleculaires des hemopathies malignes (GBMHM). [Recommendations from the French CML Study Group (Fi-LMC) for BCR-ABL1 kinase domain mutation analysis in chronic myeloid leukemia]. Bull Cancer. 2020 Jan;107(1):113-128. doi: 10.1016/j.bulcan.2019.05.011. Epub 2019 Jul 26. French. — View Citation
Ernst T, Hoffmann J, Erben P, Hanfstein B, Leitner A, Hehlmann R, Hochhaus A, Muller MC. ABL single nucleotide polymorphisms may masquerade as BCR-ABL mutations associated with resistance to tyrosine kinase inhibitors in patients with chronic myeloid leukemia. Haematologica. 2008 Sep;93(9):1389-93. doi: 10.3324/haematol.12964. Epub 2008 Jul 4. — View Citation
Soverini S, De Benedittis C, Castagnetti F, Gugliotta G, Mancini M, Bavaro L, Machova Polakova K, Linhartova J, Iurlo A, Russo D, Pane F, Saglio G, Rosti G, Cavo M, Baccarani M, Martinelli G. In chronic myeloid leukemia patients on second-line tyrosine kinase inhibitor therapy, deep sequencing of BCR-ABL1 at the time of warning may allow sensitive detection of emerging drug-resistant mutants. BMC Cancer. 2016 Aug 2;16:572. doi: 10.1186/s12885-016-2635-0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sex of patients in the Chronic Myeloid Leukemia group | Male/Female | 1-6 months after collecting last sample | |
Other | Age of patients in the Chronic Myeloid Leukemia group | The age of patients in the Chronic Myeloid Leukemia group will be recorded in years | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: White blood cells | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Red blood cells | Measured in cells/mcL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Hemoglobin | Measured in g/dL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Hematocrit | Measured in L/L | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Mean Corpuscular Volume | Measured in f/L | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Mean Corpuscular Hemoglobin | Measured in pg | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Mean Corpuscular Hemoglobin Concentration | Measured in g/L | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Red cell Distribution Width | Measured in % | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Platelets | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Neutrophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Lymphocytes | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Monocytes | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Eosinophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Chronic Myeloid Leukemia group: Basophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Date and time of sampling in the Chronic Myeloid Leukemia group | The date and time of sampling will be recorded for the Chronic Myeloid Leukemia group | 1-6 months after collecting last sample | |
Other | Myelogram in the in the Chronic Myeloid Leukemia group | A myelogram will be performed for each patient in the Chronic Myeloid Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | Osteo medullar Biopsy in the Chronic Myeloid Leukemia group | An Osteo Medullar Biopsy will be performed for each patient in the Chronic Myeloid Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | Karyotype in the Chronic Myeloid Leukemia group | Karyotyping will be performed for each patient in the Chronic Myeloid Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | BcrAbl1 in the Chronic Myeloid Leukemia group | The number of copies of BcrAbl1 per 100 copies of total Abl1 (Abl1+BcrAbl1) will be recorded for each patient in the Chronic Myeloid Leukemia group | 1-6 months after collecting last sample | |
Other | Resistance mutation rate in the Chronic Myeloid Leukemia group | The number of copies of BcrAbl1 carrying the monitored resistance mutation per 1000 copies of Abl1 (possibly, the % of mutated BcrAbl1 copies per 100 copies of BcrAbl1: the latter is not an absolute parameter) will be recorded. | 1-6 months after collecting last sample | |
Other | Number of innate LT CD8+ cells in the Chronic Myeloid Leukemia group | This will be recorded as a % of total LT CD8 cells | 1-6 months after collecting last sample | |
Other | Sex of patients in the Philadelphia+ Acute Lymphoblastic Leukemia group | Male/Female | 1-6 months after collecting last sample | |
Other | Age of patients in the Philadelphia+ Acute Lymphoblastic Leukemia group | The age of patients in the Philadelphia+ Acute Lymphoblastic Leukemia group will be recorded in years | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: White blood cells | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Red blood cells | Measured in cells/mcL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Hemoglobin | Measured in g/dL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Hematocrit | Measured in L/L | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Mean Corpuscular Volume | Measured in f/L | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Mean Corpuscular Hemoglobin | Measured in pg | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Mean Corpuscular Hemoglobin Concentration | Measured in g/L | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Red cell Distribution Width | Measured in % | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Platelets | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Neutrophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Lymphocytes | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Monocytes | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Eosinophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Blood count in the Philadelphia+ Acute Lymphoblastic Leukemia group: Basophils | Measured in K/uL | 1-6 months after collecting last sample | |
Other | Date and time of sampling in the Philadelphia+ Acute Lymphoblastic Leukemia group | The date and time of sampling will be recorded for the Philadelphia+ Acute Lymphoblastic Leukemia group | 1-6 months after collecting last sample | |
Other | Myelogram in the Philadelphia+ Acute Lymphoblastic Leukemia group | A myelogram will be performed for each patient in the Philadelphia+ Acute Lymphoblastic Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | Osteo Medullar Biopsy in the Philadelphia+ Acute Lymphoblastic Leukemia group | An Osteo Medullar Biopsy will be performed for each patient in the Philadelphia+ Acute Lymphoblastic Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | Karyotype in the Philadelphia+ Acute Lymphoblastic Leukemia group | Karyotyping will be performed for each patient in the Philadelphia+ Acute Lymphoblastic Leukemia group and qualitatively analyzed | 1-6 months after collecting last sample | |
Other | BcrAbl1 in the Philadelphia+ Acute Lymphoblastic Leukemia group | The number of copies of BcrAbl1 per 100 copies of total Abl1 (Abl1+BcrAbl1) will be recorded for each patient in the Philadelphia+ Acute Lymphoblastic Leukemia group | 1-6 months after collecting last sample | |
Other | Resistance Mutation Rate in the Philadelphia+ Acute Lymphoblastic Leukemia group | The number of copies of BcrAbl1 carrying the monitored resistance mutation per 1000 copies of Abl1 (possibly, the % of mutated BcrAbl1 copies per 100 copies of BcrAbl1: the latter is not an absolute parameter) will be recorded. | 1-6 months after collecting last sample | |
Other | Number of innate LT CD8+ cells in the Philadelphia+ Acute Lymphoblastic Leukemia group | This will be recorded as a % of total LT CD8 cells | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: mutated BcrAbl1 | The number of copies of mutated BcrAbl1 / 1000 copies of Abl1 will be measured. | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of BcrAbl1 | The percentage of BcrAbl1 will be measured against total Abl1 | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of innate CD8+ T cells | The percentage of innate CD8+ T cells will be measured against total CD8+ T cells. | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:mutated BcrAbl1 | The number of copies of mutated BcrAbl1 / 1000 copies of Abl1 will be measured. | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of BcrAbl1 | The percentage of BcrAbl1 will be measured against total Abl1 | 1-6 months after collecting last sample | |
Primary | Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of innate CD8+ T cells | The percentage of innate CD8+ T cells will be measured against total CD8+ T cells | 1-6 months after collecting last sample | |
Secondary | Association between the rate of innate CD8+ T cells and the molecular response during Chronic myeloid Leukemia. | In patients with Chronic Myeloid Leukemia, data from the patient file will be used to qualitatively analyse the nature of BcrABl1 transcripts. | 1-6 months after collecting last sample | |
Secondary | Association between the rate of innate CD8+ T cells and the molecular response during Philadelphia + Acute Lymphoblastic Leukemia | In patients with Philadelphia + Acute Lymphoblastic Leukemia data from the patient file will be used to qualitatively analyse the nature of BcrABl1 transcripts. | 1-6 months after collecting last sample |
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