(Pharmacology) an alkylating drug derived from nitrogen mustard, administered orally in the treatment of leukaemia and other malignant diseases. Formula: C14H19Cl2NO2
The primary endpoint is progression-free survival (PFS) in the CALQUENCE and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the CALQUENCE monotherapy arm compared to the chlorambucil and obinutuzumab arm.
Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL.
The primary endpoint is that the combination registered a statistically-significant improvement in progression-free survival during the trial, as compared to the chemotherapy-based combination of chlorambucil and obinutuzumab.
According to the company, this trial met its primary endpoint of Calquence in combination with obinutuzumab demonstrating a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.
The primary endpoint was the demonstration of "statistically-significant and clinically-meaningful" improvement in progression-free survival from the combination of Calquence and obinutuzumab against chemotherapy-based treatment of chlorambucil and obinutuzumab.
The trial met its primary endpoint; Calquence in combination with obinutuzumab demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.
Hence, standard chemotherapy agents, such as chlorambucil, bendamustine, cladribine or fludarabine, etc., are not prescribed as first line therapy as they may affect the stem cells.
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