Acute Myeloid Leukemia MedDRA version: 20.0 Level: LLT Classification code 10060558 Term: Acute myeloid leukemia recurrent System Organ Class: 100000012987
Conditions
Interventions
Trade Name: Vyxeos
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Cytarabine
CAS Number: 147-94-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Cincinnati Children's Hospital Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 1-21 yrs at the time of study enrollment - Diagnosis of a hematologic malignancy [acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or aggressive lymphoma] - Karnofsky = 50% for patients > 16 years of age and Lansky = 50 for patients =16 years of age - Patients must have fully recovered from acute toxicities of prior therapy - Adequate Organ Function requirements, defined as: o Platelet count = 20 X 109/L (20,000/mcgL) (may receive platelet transfusion) o Hemoglobin = 8.0 g/dL (may receive RBC transfusion) o Adequate serum creatinine based on age/gender or a 24 hour creatinine clearance/ radioisotope determined GFR = 70mL/min/1.73 m2 o Direct bilirubin = 1.5 X upper limit of normal (ULN) for age o SGPT (ALT) , 5.0 X ULN for age and institution (unless elevation is related to leukemia involvement) o Shortening fraction of =27% by echocardiogram, or Ejection fraction of = 50% by gated radionuclide study or echocardiogram Are the trial subjects under 18? yes Number of subjects for this age range: 27 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with Acute Promyelocytic Leukemia (APML), Down Syndrome, Fanconi Anemia, ALL and CNS leukemia (CNS status 3). - Pregnant or breast-feeding women and males or females of reproductive potential unwilling to use an effective contraceptive method. - Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment. - Patients who are currently receiving another investigational drug or anti-cancer agents (with the exception of intrathecal cytarabine and oral hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to initiation of protocol therapy). - Patients who have an uncontrolled infection, history of Wilson’s disease or other copper metabolism, had major surgery within 4 weeks of enrollment or received prior radiation to the mediastinum. - Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine a safe and tolerable dose of CPX-351 in children and adolescents with relapsed or refractory hematopoietic malignancies and to recommend a dose for future studies.;Secondary Objective: To estimate the overall response rate to a single course of CPX-351 to young patients with recurrent or refractory hematologic malignancies.;Primary end point(s): ? Determine rate of dose limiting toxicities ? Number of participants with dose limiting toxicities to determine maximum tolerated dose ? Pharmacokinetics: Serum concentration of CPX-351 components and metabolites ;Timepoint(s) of evaluation of this end point: ? Day 56 ? Day 56 ? Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Overall response rate after a single course of CPX-351 ? Electrocardigram, echocardiogram, peripheral blood cardiac troponin-T (cTn-T) and brain natriuretic peptide (BnP);Timepoint(s) of evaluation of this end point: ? Day 28 ? Day 30 | — |
Countries
United States
Contacts
Public ContactClinical Trial Disclosure
Jazz Pharmaceuticals
Outcome results
None listed