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Clinical Trials/EUCTR2021-000678-27-FR
EUCTR2021-000678-27-FRActive, not recruitingPhase 1

A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

ovartis Pharma AG0 sites402 target enrollmentStarted: June 28, 2021Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
402
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Participants eligible for inclusion in this study must meet all of the following criteria:
  • •1. Male or female patients = 18 years of age.
  • •2. Patients with CML-CP within 3 months of diagnosis.
  • •3. Diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL1 in a review of a minimum 20 metaphases is required).
  • •- Documented chronic phase CML will meet all the below criteria Hochhaus et al 2020:
  • •< 15% blasts in peripheral blood and bone marrow,
  • •< 30% blasts plus promyelocytes in peripheral blood and bone marrow,
  • •< 20% basophils in the peripheral blood,
  • •Platelet count = 100 x 109/L (= 100,000/mm3),
  • •No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
  • •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1.
  • •5. Adequate end organ function as defined by:
  • •Total bilirubin < 3 x ULN; patients with Gilbert’s syndrome may only be included if total bilirubin = 3.0 x ULN or direct bilirubin = 1.5 x ULN
  • •Creatinine clearance (ClCr) = 30 mL/min as calculated using Cockcroft-Gault formula,
  • •Serum lipase = 1.5 x ULN. For serum lipase > ULN - = 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
  • •6. Patients must have the following laboratory values = LLN or corrected to within normal limits with supplements prior to randomization:
  • •Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with ClCr* = 90 mL/min)
  • •Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with ClCr* = 90 mL/min)
  • •Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with ClCr* = 90 mL/min)
  • •For patients with mild to moderate renal impairment (ClCr* = 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be = LLN or corrected to within normal limits with supplements prior to randomization.
  • •*ClCr as calculated using Cockcroft-Gault formula
  • •7. Ability to provide written informed consent prior to any study related screening procedures being performed.
  • •8. Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which are amenable to standardized RQ-PCR quantification.
  • •9. Other protocol-defined inclusion criteria may apply
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 100
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

  • •1.Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with imatinib for =2 weeks is allowed, but no other treatment with tyrosine kinase inhibitors prior to study entry is permitted.
  • •2.Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
  • •3.Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:
  • •History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
  • •Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
  • •QTc = 450 msec (male patients), =460 msec (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF = 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
  • •Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
  • •Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
  • •Concomitant medication(s) with a Known risk of Torsades de Pointes” per www.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
  • •Inability to determine the QTcF interval
  • •4.Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia). Please refer to Section 6.3.1
  • •5.History of significant congenital or acquired bleeding disorder unrelated to cancer.
  • •6.Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
  • •7.History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively
  • •8.History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
  • •9.History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
  • •10. Other protocol-defined exclusion criteria may apply

Investigators

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