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Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.

Recruitingn/aAges any - anyAllFondazione IRCCS Policlinico San Matteo di Pavia
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In plain words

What the trial is, and whether it could suit you

Venetoclax (VEN) is a potent and selective oral inhibitor of the BCL-2 gene and has shown anti-leukemic activity when used in combination with hypomethylating agents (HMA) in patients with Acute Myeloid Leukemia (AML), both newly diagnosed and in relapse or refractory (R/R) stages. A daily dose of 400 mg has shown the best results in terms of efficacy, toxicity, and low early mortality rates (DiNardo et al., Blood 2019). The HMA-VEN combination has been approved for the treatment of newly diagnosed AML patients who are not candidates for intensive therapy. However, although this treatment is considered low-intensity, it causes a non-negligible toxicity profile, especially hematological toxicity, even in patients who have already achieved remission. As a result, treatment often needs to be interrupted, and VEN dosage adjusted in subsequent cycles. An analysis by Pratz et al. (Pratz et al

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * patients with newly diagnosed Acute Myeloid Leukemia treated with HMA-VEN in disease remission (from the first post-remission cycle). Exclusion Criteria: * undergoing treatment with moderate or strong Cytochrome 3A4 inhibitors or inducers, * unwilling to receive treatment as previously specified and to be tested for VEN plasma levels at the previously specified timepoint.
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What it tests

  • Not listed
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Where

1 site
Fondazione IRCCS Policlinico San Matteo, SC Oncologia
Pavia, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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