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Clinical picture: CML (Chronical Myeloide Leukemia)
Trial: HOVON 142 CML -SUSTRENIM-CML1415
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
This is a prospective, interventional, randomized, two arms, study evaluating both the depth of the molecular response and the rate of treatment free remission rate in newly diagnosed CP-CML patients treated with NIL or IM followed by switch to NIL in absence of optimal response (defined according the ELN 2013 criteria) as per clinical practice.
Fondiazione GIMEMA in association with HOVON
Type of study
Prospective randomized Phase III study
Level C-HIC & C-SCT
Type of monitoring for this study
Site evaluation visits
Target number of patients
Date of first EC&CA submission
cEC Italy: 08-08-2016
EC VUMC: 22-06-2018
Change history / amendement
EC VUMC: 2-11-2018
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria using two primary end-points:
− To evaluate the rates of molecular response (MR4.5) at 24 months
− To evaluate the rate of patients who remain in sustained treatment free remission (≥MR3.0) without molecular relapse 12 months after entering the TFR phase. The molecular relapse is defined as loss of MMR, or confirmed loss of MR3.0.
2. Patient eligibility criteria
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:
< 15% blasts in peripheral blood
< 30% blasts plus promyelocytes in peripheral blood
< 20% basophils in the peripheral blood
≥ 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.
Previous treatment with BCR-ABL inhibitors for more than 30 days.
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.
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.
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.