A Phase 4 study evaluating the effect of GO (MYLOTARG™) on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent therapy in patients with relapsed or refractory blood cancer.
- Conditions
- relapsed or refractory CD33-positive acute myeloid leukaemia (AML)MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-002619-89-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 51
1. Refractory or relapsed (ie, bone marrow blasts =5%) CD33-positive AML.
2. Age=12 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
4. Initial peripheral white blood cells (WBC) counts <30,000/ µL;
patients with a higher WBC count should undergo cytoreduction.
5. Adequate renal/hepatic functions, ie:
- Serum creatinine =1.5 x upper limit of normal (ULN) or any serum
creatinine level associated with a measured or calculated creatinine
clearance of =40 mL/min;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
<2.5×ULN; total bilirubin <2×ULN.
6. Negative serum or urine pregnancy (human chorionic gonadotropin
[hCG]) test within 1 week before treatment for women of child bearing
potential.
7. Evidence of a personally signed and dated informed consent document
and obtaining proper pediatric assent in addition to consent according to
local regulations (by the caregivers or legally acceptable representative
[eg, parents] in the pediatric patients) indicating that the patient [or a legally acceptable representative/parent(s)/legal guardian] has been informed of all pertinent aspects of the study.
8. Willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
9. Female patients of non-childbearing potential must meet at least 1 of
the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of
regular menses for at least 12 consecutive months with no alternative
pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure.
All other female patients (including female patients with tubal ligations) are considered to be of childbearing potential.
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Patients with prior treatment with GO.
2. Patients with prior history of VOD/SOS.
3. Prior HSCT is not allowed, if it was conducted within 2 months prior to
study enrollment.
4. Patients with known active central nervous system (CNS) leukemia.
5. Uncontrolled or active infectious status.
6. Any of the following within the 3 months prior to starting study
treatment: myocardial infarction, severe/unstable angina,
coronary/peripheral artery bypass graft, congestive heart failure, or
cerebrovascular accident including transient ischemic attack, or
symptomatic pulmonary embolism.
7. Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2,
uncontrolled atrial fibrillation of any grade.
8. Sero-positivity to human immunodeficieny virus (HIV).
9. Active hepatitis B or hepatitis C infection (see Appendix 2 of the protocol).
10. Chemotherapy, radiotherapy, or other anti-cancer therapy (except
hydroxyurea as cytoreduction) within 2 weeks prior to enrollment in the
study.
11. Major surgery within 4 weeks prior to enrollment.
12. Diagnosis of any other malignancy within 3 years prior to enrollment,
except for adequately treated basal cell or squamous cell skin cancer, or
carcinoma in situ of the cervix.
13. QTc interval >470 milliseconds (msec) using the Fridericia (QTcF)
(based on the mean value of the triplicate electrocardiograms [ECGs]),
family or personal history of long or short QT syndrome, Brugada
syndrome or known history of QTc prolongation, or Torsade de Pointes
(TdP).
14. The use of medications known to predispose to Torsades de Pointes
within 2 weeks prior to enrollment (see Appendix 4 of the protocol).
15. History of allergic reactions attributed to compounds of similar
chemical or biologic composition to GO.
16. Investigator site staff members directly involved in the conduct of
the study and their family members, site staff members otherwise
supervised by the investigator, or patients who are Pfizer employees,
including their family members, directly involved in the conduct of the
study.
17. Participation in other studies involving investigational drug(s) within
2 weeks prior to study entry and/or during study participation.
18. Other acute or chronic medical or psychiatric condition including
recent (within the past year) or active suicidal ideation or behavior or
laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere
with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this
study.
19. Pregnant female patients; breastfeeding female patients; fertile male
patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception as outlined
in this protocol for the duration of the study and for 7 months after the
last dose of investigational product.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method