Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Official Title

A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA

Summary:

This is a single‑arm, open‑label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single‑agent monotherapy in adult and pediatric patients with relapsed or refractory CD33‑positive AML.

Trial Description

This is a single‑arm, open‑label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single‑agent monotherapy in adult and pediatric patients with relapsed or refractory CD33‑positive AML. Approximately 50 adult (age >=18 years) and 6 pediatric (12 years =< age =< 17 years) patients who satisfy the study eligibility criteria will be enrolled. Enrolled patients will receive GO 3 mg/m2 up to 2 cycles on Days 1, 4, and 7 at each cycle. The impact of GO on VOD/SOS in the context of previous and subsequent HSCT will also be assessed. Patients enrolled in the study will receive three doses of GO 3 mg/m2 (up to one vial) as a 2‑hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the following criteria after Cycle 1: Bone marrow with a decrease of blast percentage to at least 25% or a decrease of pretreatment blast percentage by at least 50%; and Blood count with neutrophils >=1,000/µL, and platelets >=50,000/µL, except in patients with the bone marrow blasts >=5%, the decrease in neutrophils and platelets thought to be due to the underlying leukemia. After GO treatment, subsequent anticancer therapy such as consolidation or conditioning regimen and/or HSCT could be considered at the investigator's discretion. A minimum interval of 2 months is recommended between the last dose of GO and HSCT.

Primary Outcome Measures :

  • Corrected QTc interval change from baseline in ECG during Cycle 1-2
Secondary Outcome Measures :
  • Clearance of total hP67.6 antibody, conjugated calicheamicin, and unconjugated calicheamicin in Liter/Hour
  • Volume of distribution of total hP67.6 antibody, conjugated calicheamicin, and unconjugated calicheamicin in Liter
  • Rate of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.03
  • Rate of Participants With Abnormalities of Laboratory Tests as Assessed by CTCAE v4.03
  • Incidence of the immunogenicity of anti-drug antibody (ADA)/neutralizing antibodies (NAb)
  • Response rate of complete remission and complete remission with incomplete hematologic recovery
  • Overall survival in months

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society