Clinical Trials Logo
  1. Home
  2. Chronic Myeloid Leukemia
  3. NCT05753384

Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System

Chronic Myeloid Leukemia Clinical Trial

Official title:
Discontinuation of TyrosIne Kinase Inhibitors (ITK) in Chronic Myeloid Leukemia (LMC) and Impact on the Immune System: a Randomized Comparative Study of Two Therapeutic Strategies

Clinical Trial Summary

Tyrosine kinase inhibitors (TKI) have revolutionized the management and prognosis of chronic myeloid leukemia (CML). Daily treatment with TKI, which is necessary due to lack of cure, is frequently associated with moderate, chronic and sometimes severe adverse effects. The ability to permanently stop treatment with TKI has thus become a major goal in CML to prevent the occurrence of adverse events, improve quality of life and reduce the general cost of the treatment; we talk about Treatment Free Remission (TFR). It now remains to be demonstrated in a comparative prospective study that a strategy of de-escalation of the TKI treatment dose before treatment discontinuation optimizes TFR results. At the same time, it is possible to reduce adverse reactions and improve the quality of life of patients. In this context, the investigator propose to conduct a randomized clinical trial including CML patients, allowing to compare the results of TFR at 24 months between a sudden stop of treatment after a maintenance phase of dosage for 12 months and a de-escalation arm of dose (dosage reduced by 50%) for 12 months before stopping. A secondary immunological translational objective of this project will be to compare the quantitative and qualitative evolution of innate CD8 T cells between the 2 arms (abrupt cessation of ITK treatment versus progressive withdrawal) and look for a predictive innate CD8 T cells blood signature at the time of stopping treatment of a successful TFR in both arms.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05753384
Study type Interventional
Source Poitiers University Hospital
Contact Emilie Cayssials-Caylus, Dr
Phone c
Email emilie.cayssials@chu-poitiers.fr
Status Recruiting
Phase Phase 3
Start date December 1, 2023
Completion date December 1, 2029
View Details
See also
  Status Clinical Trial Phase
Suspended NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT02057185 - Occupational Status and Hematological Disease
Recruiting NCT03326310 - Selumetinib and Azacitidine in High Risk Chronic Blood Cancers Phase 1
Recruiting NCT04621851 - Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Completed NCT01207440 - Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 2
Active, not recruiting NCT02917720 - 2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients Phase 2
Not yet recruiting NCT02883036 - Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia N/A
Withdrawn NCT01188889 - RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease. Phase 1/Phase 2
Completed NCT01795716 - Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body Phase 1
Completed NCT00988013 - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies N/A
Approved for marketing NCT00905593 - Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Phase 3
Terminated NCT00573378 - Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia Phase 2
Terminated NCT00522990 - Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias Phase 1/Phase 2
Completed NCT00469014 - Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia Phase 2
Completed NCT00257647 - Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML) N/A
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT00219739 - STI571 ProspectIve RandomIzed Trial: SPIRIT Phase 3
Completed NCT06148493 - Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
Completed NCT00375219 - Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation Phase 2
Completed NCT04605211 - A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors N/A