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Report for Clinical Trial NCT04360005

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Managed Access Program (MAP) to Provide Access to Asciminib for Patients With CML in Chronic Phase, With or Without Documented T315I Mutation, Without Comparable or Satisfactory Alternative Therapy to Treat the Disease

This program provides access to asciminib for patients with CML in chronic phase, with or without documented T315I mutation, without comparable or satisfactory alternative therapy to treat the disease

NCT04360005 Chronic Myeloid Leukemia
MeSH:Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Myeloid leukemia

1 Interventions

Name: Asciminib

Description: Asciminib 20 or 40 mg strength tablets will be administered orally twice-daily, without food
Type: Drug



There is one SNP

SNPs


1 T315I

Managed Access Program (MAP) to Provide Access to Asciminib for Patients With CML in Chronic Phase, With or Without Documented T315I Mutation, Without Comparable or Satisfactory Alternative Therapy to Treat the Disease. --- T315I ---

Managed Access Program (MAP)* to Provide Access to Asciminibfor Patients With CML in Chronic Phase This program provides access to asciminib for patients with CML in chronic phase, with or without documented T315I mutation, without comparable or satisfactory alternative therapy to treat the disease Inclusion Criteria: Patients eligible for inclusion in this treatment plan have to meet all of the following criteria: Written patient informed consent must be obtained prior to start of treatment, including all necessary consents (or their legal representatives, where applicable). --- T315I ---

- Male or female patients ≥ 18 years of age - Patients with CML in chronic phase with or without T315I mutation, who were previously treated with all commercially available tyrosine kinase inhibitors (TKIs) for the specific market and are relapsed, refractory to or intolerant of TKIs as determined by the treating physician or for whom the treatment with one or more available TKIs is contraindicated based on approved label - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - Patient is deemed by the treating physician to have the initiative and means to be compliant with treatment and follow-up requested - Adequate end organ function, within 14 days before the first dose of asciminib treatment, as defined by: - Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN - Aspartate transaminase (AST) ≤ 3.0 x ULN - Alanine transaminase (ALT) ≤ 3.0 x ULN - Serum lipase ≤ 1.5 x ULN. --- T315I ---



HPO Nodes


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