Drug intelligence / Profile preview

cladribine + cytarabine + granulocyte-colony stimulating factor + fractionated gemtuzumab ozogamicin

Development stage
Unknown
Lead developer
Merck
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous, Subcutaneous
01

Overview

This is a combination chemotherapy regimen consisting of cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF), and fractionated gemtuzumab ozogamicin. It is primarily used in the treatment of acute myeloid leukemia (AML), particularly in relapsed or refractory cases and high-grade myeloid neoplasms. - **Cladribine** is a purine nucleoside analog that inhibits DNA synthesis, leading to cell death in rapidly dividing cells. - **Cytarabine** is an antimetabolite that interferes with DNA synthesis by inhibiting DNA polymerase. - **Granulocyte colony-stimulating factor (G-CSF)** stimulates the proliferation and differentiation of neutrophil precursors to reduce neutropenia associated with intensive chemotherapy[6][9]. - **Fractionated gemtuzumab ozogamicin** is an antibody-drug conjugate targeting CD33 on leukemic blasts; it consists of a humanized anti-CD33 monoclonal antibody linked to calicheamicin, a potent cytotoxic agent[5][8]. Fractionated dosing refers to administering smaller doses over several days (commonly 3 mg/m² on days 1, 4, and 7) for improved safety without loss of efficacy[7][10]. The combination has shown promising results in clinical trials for AML patients who are newly diagnosed or have relapsed/refractory disease. The regimen aims to maximize anti-leukemic activity while managing toxicity through supportive care with G-CSF[2][3].

Other names
CLAG-GOCLAG-GO3CLAG-GO-3CLAG-GO 3
02

Targets

CD33 (Myeloid cell surface antigen CD33)CSF3R (Granulocyte colony-stimulating factor receptor)DNADNA polymerase family

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