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Sustained treatment-free period in the course of a disease when symptoms become less severe in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing a drug called Nilotinib versus another called Imatinib with switch to Nilotinib in absence of optimal response.
EU CTIS ID: 2023-510434-83-00
What this study is testing
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by a switch to NIL in the case of absence of an optimal response as defined by ELN criteria.
- Therapeutic use (Phase IV)
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 eligible for inclusion in this study have to meet all of the following criteria: • Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase o Documented chronic phase CML must meet all the following criteria: 1. < 15% blasts in peripheral blood 2. < 30% blasts plus promyelocytes in peripheral blood 3. < 20% basophils in the peripheral blood 4. = 100 x 109/L (= 100,000/mm3) platelets
- Age =18
- ECOG performance status of 0-2
- Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
- Adequate end organ function as defined by: o Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab). Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade < 3 o SGOT (AST) and SGPT (ALT) = 3 x ULN o Serum amylase and lipase = 2 x ULN o Alkaline phosphatase = 2.5 x ULN o Serum creatinine < 1.5 x ULN
- Written informed consent prior to any study procedures.
You likely can't join if
- Previous treatment with BCR-ABL inhibitors for more than 30 days.
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
- Patients unable to understand and to comply with study instructions and requirements
- Refusal to give informed consent.
- Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.
See the full eligibility criteria
Who can join
- Patients eligible for inclusion in this study have to meet all of the following criteria: • Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase o Documented chronic phase CML must meet all the following criteria: 1. < 15% blasts in peripheral blood 2. < 30% blasts plus promyelocytes in peripheral blood 3. < 20% basophils in the peripheral blood 4. = 100 x 109/L (= 100,000/mm3) platelets
- Age =18
- ECOG performance status of 0-2
- Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
- Adequate end organ function as defined by: o Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab). Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade < 3 o SGOT (AST) and SGPT (ALT) = 3 x ULN o Serum amylase and lipase = 2 x ULN o Alkaline phosphatase = 2.5 x ULN o Serum creatinine < 1.5 x ULN
- Written informed consent prior to any study procedures.
What rules you out
- Previous treatment with BCR-ABL inhibitors for more than 30 days.
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
- Patients unable to understand and to comply with study instructions and requirements
- Refusal to give informed consent.
- Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.
- Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for more than three months.
- Poorly controlled diabetes mellitus (defined as HbA1c >8%
- Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina as defined at page 30 in Exclusion Criteria.
- Uncontrolled hypertension
- History of peripheral arterial occlusive disease.
- History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis
- Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which cannot be either discontinued or switched to a different medication prior to starting study drug
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, 18-64 years, 65+ 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.