Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Hematologic Malignancy, Myelodysplastic Syndromes
Conditions
Brief summary
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
Interventions
DRUGCPX-351
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and voluntarily give informed consent. 2. Male or female patients, age ≥18 years at the time of consent. 3. Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse. 4. Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula. 5. Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351. 6. Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
Exclusion criteria
1. Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study. 2. Patients with active (uncontrolled, metastatic) second malignancies are excluded. 3. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent. 4. Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products. 5. Female patients who are pregnant, nursing, or lactating. 6. Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study. 7. Any other condition that would cause a risk to patients if they participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of CPX-351 | Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start. | The key PK parameter AUCtau will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of the individual components of CPX-351, and their respective metabolites | Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start. | The key PK parameter AUCtau will be assessed |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Up to 31 months. | TEAEs are defined as any AE starting after the initiation of the first infusion. |
Countries
Canada, United States
Outcome results
None listed