A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients with CML-CP within 3 months of diagnosis.

• Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome

• Documented chronic phase CML will meet all the below criteria Baccarani et al 2013:

• < 15% blasts in peripheral blood and bone marrow,

• < 30% blasts plus promyelocytes in peripheral blood and bone marrow,

• < 20% basophils in the peripheral blood,

• PLT count ≥ 100 x 10^9/L (≥ 100,000/mm3), except treatment induced thrombocytopenia

• No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.

• Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment.

• ECOG performance status of 0 or 1.

• Adequate end organ function as defined by:

• Total bilirubin (TBL) < 3 x ULN; patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN,

• CrCl ≥ 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.

• Patients must have the following laboratory values within normal limits 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 CrCl* ≥ 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 CrCl* ≥ 90 mL/min),

• Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min),

• For patients with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be within normal limits or corrected to within normal limits with supplements prior to randomization.

• CrCl as calculated using Cockcroft-Gault formula.

Locations
Other Locations
France
Novartis Investigative Site
Recruiting
Bordeaux
Novartis Investigative Site
Recruiting
Nantes Cedex 1
Novartis Investigative Site
Recruiting
Paris Cedex 10
Novartis Investigative Site
Recruiting
Toulouse
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy Cedex
Germany
Novartis Investigative Site
Recruiting
Aachen
Novartis Investigative Site
Recruiting
Bayreuth
Novartis Investigative Site
Recruiting
Chemnitz
Novartis Investigative Site
Recruiting
Halle S
Novartis Investigative Site
Recruiting
Hannover
Novartis Investigative Site
Recruiting
Jena
Novartis Investigative Site
Recruiting
Ulm
Novartis Investigative Site
Recruiting
Velbert
Hungary
Novartis Investigative Site
Recruiting
Budapest
Novartis Investigative Site
Recruiting
Eger
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: November 21, 2022
Estimated Completion Date: March 15, 2027
Participants
Target number of participants: 541
Treatments
Experimental: Asciminib
Participants will receive asciminib 80 mg QD
Active Comparator: Nilotinib
Participants will receive nilotinib 300 mg BID
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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