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A Prospective Phase II Clinical Trial Evaluating the Efficacy and the Safety of Tyrosine Kinase Inhibitors Withdrawal After a Previous Two-step Dose Reduction in Patients With Chronic Myeloid Leukemia in Deep Molecular Remission
EU CTIS ID: 2024-514592-17-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of tyrosine kinase inhibitor discontinuation during and after a two-step dose reduction in patients with chronic myeloid leukemia in deep remission
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with documented Ph1-positive and / or BCR-ABL1-positive CML in a documented first chronic phase, the criteria of which are as follows: <15% blasts in peripheral blood (PB) or bone marrow (BM); <30% blasts + promyelocytes in PB or BM; <20% of basophils in PB; >= 100 billion / l platelets; Absence of extramedullary involvement except hepato- and / or splenomegaly
- Age >= 18 years
- Signed informed consent to study participation
- Typical [e13a2 (b2a2) or e14a2 (b3a2)] or atypical quantifiable type of BCR-ABL1 transcript on an international scale
- Treatment of TKI either in the first line or in the second or other lines for intolerance only
- TKI treatment> 4 years
You likely can't join if
- Patients with Ph1-positive and / or BCR-ABL1-positive CML in the second chronic phase, in the accelerated phase or blast crisis (AP/BC) at any time in the history of the disease
- Pregnancy and breastfeeding
- Disagreement or impossibility to comply with the contraceptive measures described in point 9 of the inclusion criteria
- Non-quantifiable type of BCR-ABL1 transcript on an international scale
- Treatment of TKI in the second or subsequent lines due to treatment failure according to ELN (European LeukemiaNet) criteria in 2006, 2009 or 2013
- Previous failure of TKI treatment according to ELN criteria of 2006, 2009 or 2013
See the full eligibility criteria
- Patients with documented Ph1-positive and / or BCR-ABL1-positive CML in a documented first chronic phase, the criteria of which are as follows: <15% blasts in peripheral blood (PB) or bone marrow (BM); <30% blasts + promyelocytes in PB or BM; <20% of basophils in PB; >= 100 billion / l platelets; Absence of extramedullary involvement except hepato- and / or splenomegaly
- Age >= 18 years
- Signed informed consent to study participation
- Typical [e13a2 (b2a2) or e14a2 (b3a2)] or atypical quantifiable type of BCR-ABL1 transcript on an international scale
- Treatment of TKI either in the first line or in the second or other lines for intolerance only
- TKI treatment> 4 years
- Previous interferon-α treatment allowed with any treatment effect (intolerance / failure)
- Deep molecular response >= MR4.0 lasting > 2 years
- Participants in a fertile clinical trial must agree to use prescribed contraceptive methods from entry to study until one year after the last dose of study medication: Women - Proper use of a highly reliable contraceptive method, ie combined hormonal contraceptives (in oral, vaginal or transdermal dosage form), gestagen hormonal contraceptives associated with ovulation inhibition (in oral or injectable dosage form), non-hormonal IUDs (intrauterine device) or IUDs , ev. presence of bilateral tubular occlusion, partner vasectomy, or adherence to sexual abstinence; Men - Observance of sexual abstinence or use of adequate contraceptive method (ie condom) in the case of sexual intercourse for the period from enrollment to 1 year after the last dose of the drug
- Patients with Ph1-positive and / or BCR-ABL1-positive CML in the second chronic phase, in the accelerated phase or blast crisis (AP/BC) at any time in the history of the disease
- Pregnancy and breastfeeding
- Disagreement or impossibility to comply with the contraceptive measures described in point 9 of the inclusion criteria
- Non-quantifiable type of BCR-ABL1 transcript on an international scale
- Treatment of TKI in the second or subsequent lines due to treatment failure according to ELN (European LeukemiaNet) criteria in 2006, 2009 or 2013
- Previous failure of TKI treatment according to ELN criteria of 2006, 2009 or 2013
- Previous allogeneic hematopoietic stem cell transplantation
- Previous participation in a TKI withdrawal study with a real withdrawal history
- Previous discontinuation of TKI outside the study for other reasons (eg intolerance or pregnancy) lasting more than 9 months and / or if a treatment response was lost during less than 12 months prior to screening
- Life expectancy of less than 36 months due to severe concurrent disease
- Severe concurrent disease that could limit adherence to study protocol or study completion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.