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

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NCT03727750

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Study Location
Children's Healthcare of Atlanta at Egleston Hospital
Atlanta, Georgia, 30322, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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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).

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ECG, Pharmacokinetics, SafetyEvaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML NCT03727750
  1. Atlanta, Georgia
  2. Atlanta, Georgia
  3. Barcelona,
  4. Augusta, Georgia
  5. Augusta, Georgia
  6. Greenville, North Carolina
  7. Greenville, North Carolina
  8. Edmonton, Alberta
  9. Edmonton, Alberta
  10. Edmonton, Alberta
  11. Winnipeg, Manitoba
  12. Winnipeg, Manitoba
  13. Hamilton, Ontario
  14. Hamilton, Ontario
  15. Budapest,
  16. Debrecen,
  17. Gyor,
  18. Gyor,
  19. Kaposvar,
  20. Gdansk,
  21. Gdansk,
  22. Gdansk,
  23. Wroclaw,
  24. Wroclaw,
  25. Wroclaw,
  26. Barcelona,
  27. Madrid,
  28. Madrid,
  29. Valencia,
  30. Belfast, Antrim
  31. Bournemouth, Dorset
  32. Taunton, Somerset
  33. Belfast,
  34. Liverpool,
  35. Liverpool,
  36. London,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
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
  • ECG
  • Pharmacokinetics
  • Safety
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
 (submitted: October 30, 2018)		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

  • 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

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP