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NCT01698879 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment (NCT01698879)

Trial Description
Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.

Following the standard chemotherapy treatment, the complete response (CR) rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of Cytarabine (DepoCyt®; Sigma Tau Pharmaceuticals) or adding a third drug.

Gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) is an immunoconjugate (antibody-drug conjugate/ADC) between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin.

The antibody part of gemtuzumab ozogamicin specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. The drug selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.

Gemtuzumab ozogamicin was approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.*

Since the efficacy of gemtuzumab ozogamicin is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of gemtuzumab ozogamicin in the early stages of treatment of AML.

Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the complete response (CR) rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.

Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.

Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3×7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated.

This trial is sponsored by CETLAM (Grupo Cooperativo Para el Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias) [1]

Study Data

  • Condition: Novo Acute Myeloid Leukemia
  • Interventions:
  • Phase: II
  • Enrollment: 40
  • Start: October 2009
  • Estimated Completion: February 2013
  • Last verified: October 2012

Study Schematic

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* Based on results from the randomized SWOG 106 study, Pfizer voluntarily withdrew gemtuzumab ozogamicin from the market in mid-2010.

Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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