Actively Recruiting
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
Led by Celyad Oncology SA · Updated on 2020-06-09
27
Participants Needed
5
Research Sites
792 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.
CONDITIONS
Official Title
Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is not eligible for standard therapy and has relapsed or refractory AML with at least 5% blasts in bone marrow or blood after prior treatment
- Patient has relapsed or refractory MDS of intermediate to very high risk or with Tumor Protein 53 mutation after failure of at least 4 cycles of azacitidine or decitabine
- Patient has evaluable disease by international response criteria for AML or MDS
- Peripheral blast count is less than 15,000 per liter
- Patient has adequate liver and kidney function based on standard labs
- Left ventricular ejection fraction is 40% or higher as measured by echocardiography or scan
- Forced Expiratory Volume (FEV) to Forced Vital Capacity ratio is 0.7 with FEV-1 at 50% predicted or higher (GOLD 1 or 2) measured by spirometry
You will not qualify if you...
- History or presence of tumor involvement in the central nervous system
- Previous cancer therapy with therapeutic intent before study treatment
- Positive serology tests at baseline
- Received investigational agents within 3 weeks prior to first CYAD-02 infusion
- Uncontrolled illnesses or serious medical disorders
- Significant coagulation disorders or use of warfarin, heparin, or direct oral anticoagulants
- Active infections
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or active exacerbation of chronic obstructive pulmonary disease
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
2
University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
3
Uz Leuven
Leuven, Belgium, 3000
Actively Recruiting
4
Chu Liege
Liège, Belgium, 4000
Actively Recruiting
5
AZ DELTA
Roeselare, Belgium, 8800
Actively Recruiting
Research Team
F
Frederic LEHMANN, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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