Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
NCT03727750
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Adult Trials: 18+ Years
- 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
- 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).
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief 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. | ||||||
| Detailed 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single arm, open-label, interventional Masking: None (Open Label)Masking Description: open-label Primary Purpose: Treatment
| ||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Gemtuzumab Ozogamicin
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 criteria | ||||||
| Study Arms ICMJE | Experimental: Gemtuzumab Ozogamicin (GO)
Patients will receive three doses of Gemtuzumab Ozogamicin (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 criteria Intervention: Drug: Gemtuzumab Ozogamicin | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 56 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 19, 2022 | ||||||
| Estimated Primary Completion Date | March 19, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Sex/Gender ICMJE |
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| Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, Hungary, Poland, Spain, United Kingdom, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03727750 | ||||||
| Other Study ID Numbers ICMJE | B1761031 2018-002619-89 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||