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

Last updated on September 12, 2019

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Study Location
Apteka Szpitalna Uniwersyteckie Centrum Kliniczne
Gdansk, , 80-214 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ECG, Pharmacokinetics, Safety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Refractory or relapsed (ie, bone marrow blasts >5%) CD33‑positive AML.

- Age >=12 years.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.

- Initial peripheral white blood cells (WBC) counts >=30,000/mL; patients with a higher
WBC count should undergo cytoreduction.

- Adequate renal/hepatic functions

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with prior treatment with gemtuzumab ozogamicin (GO).

- Patients with prior history of VOD/SOS.

- Prior HSCT is not allowed, if it was conducted within 2 months prior to study
enrollment.

- Patients with known active central nervous system (CNS) leukemia.

- Uncontrolled or active infectious status.

- Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial
fibrillation of any grade.

- Sero?positivity to human immunodeficieny virus (HIV).

- Active hepatitis B or hepatitis C infection

- Chemotherapy, radiotherapy, or other anti?cancer therapy (except hydroxyurea as
cytoreduction) within 2 weeks prior to enrollment in the study.

- Major surgery within 4 weeks prior to enrollment.

- QTc interval >470 milliseconds (msec) using the Fridericia (QTcF), family or personal
history of long or short QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes (TdP).

- The use of medications known to predispose to Torsades de Pointes within 2 weeks prior
to enrollment

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemtuzumab ozogamicin (GO).

NCT03727750
Pfizer
Recruiting
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

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[email protected]

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ECG, Pharmacokinetics, Safety
NCT03727750
All Genders
12+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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