Chronic Myeloid Leukemia Clinical Trial
Official title:
Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia
It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?
Chronic myeloid leukemia (CML) is an hematopoietic stem cell disorder in which a t (9;22)
(q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and
generates the BCR-ABL1 fusion gene encoding a constitutively activated protein tyrosine
kinases (PTK). Tyrosine kinase Inibitors (TKIs) such as imatinib, by blocking BCR-ABL1 kinase
activity, selectively eradicate CML cells and induce durable responses and prolong survival.
CML patients treated with TKI are monitored by BCR-ABL1 RT-qPCR (Reverse Transcription
real-time quantitative Polymerase Chain Reaction) performed from peripheral blood samples.
A first multicenter study entitled STIM trial demonstrated that imatinib could be safely
discontinued in patients with complete molecular remission (CMR) for at least 2 years
(undetectable BCR-ABL1 transcript by RT-qPCR).
Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after
treatment cessation. All molecular relapsing patients were sensitive when imatinib was
re-challenged.
The purpose of this STIM-FU study is to follow all the patients included in the STIM trial in
order to evaluate their molecular status, vital status and ongoing treatment in patient with
a first molecular relapse.
This long term follow up will allow us to predict if a constant long term control of the
disease is possible and to better define the clinical and biological CML-related factors
predictive for a molecular relapse after TKI discontinuation.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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 | |
Not yet recruiting |
NCT06409936 -
PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML
|
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 | |
Completed |
NCT00469014 -
Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute 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 |
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 |