Chronic Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study to Determine the Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic-Phase Chronic Myelogenous Leukaemia
The purpose of this pilot study is to investigate whether some patients who were started on a 2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI, while maintaining or even deepening the molecular response as a cost-effective treatment. Eligible patients will be switched to imatinib 400mg daily, with regular molecular monitoring.
Imatinib, nilotinib and dasatinib are standard first-line options for newly diagnosed
patients with chronic-phase chronic myeloid leukemia (CML). While nilotinib and dasatinib,
also known as second-generation TKI (2G-TKI), have been shown to result in earlier and deeper
molecular response, they have not been proven superior to imatinib in terms of clinical
outcomes like progression-free survival and overall survival. Moreover, their long-term
safety has been questioned: nilotinib is associated with increased cardiovascular risk while
dasatinib causes pleural effusion in significant proportion of patients and may even lead to
pulmonary hypertension.
The purpose of this pilot study is to investigate whether some patients who were started on a
2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI,
while maintaining or even deepening the molecular response as a cost-effective treatment.
Eligible patients will be switched to imatinib 400mg daily, with regular molecular
monitoring.
In case of molecular progression
The following should be systematically performed:
- Clinical examination
- Baseline blood test including complete blood count (CBC), liver and renal function,
lactate dehydrogenase (LDH), urate
- Restart the original 2G-TKI and in same dose as given before study entry unless
medically indicated to change therapy
- Screening of breakpoint cluster region- Abelson murine leukemia (BCR-ABL) kinase domain
mutations
- In the absence of signs of haematological relapse or breakpoint cluster region- Abelson
murine leukemia (BCR-ABL1) ≥ 1% (IS ratio), bone marrow aspiration and cytogenetics are
not routinely performed unless deemed indicated by the physician in charge.
The patient will be followed until major molecular response (MMR) is re-achieved and further
6 months beyond. Date of progression, hematological data at progression (molecular,
cytogenetic, and hematological), and treatment proposed for molecular progression and
response to it (molecular, cytogenetic, hematological) will be collected. Follow-up for
overall survival (OS) and progression-free survival (PFS) will last 2 years since the date of
switch of TKI.
In case of loss of complete hematological response (CHR) or any sign of accelerated or
blastic phase of CML, the patient will be immediately considered as in disease progression
and TKI should be started immediately.
;
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 | |
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 | |
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 |
NCT00257647 -
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)
|
N/A | |
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 |