Hematologic Diseases Clinical Trial
Official title:
An Open-Label, Randomized, Pharmacokinetic Study of vinCRIStine Sulfate LIPOSOME Injection Ready-to-Use (VSLI-RTU) Formulation (1-Vial) and Marqibo® Formulation (3-Vials) in Patients With Hematological Malignancies
This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.
Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A
or B) in which the Marqibo formulation and the 1-vial VSLI-RTU formulation of vincristine are
administered in a 2-way crossover design over 2 treatment cycles (21 days each):
- Cohort A: Marqibo formulation given at a dose of 2.25 mg/m2 with no dose cap during
Cycle 1, and VSLI-RTU formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
- Cohort B: VSLI-RTU formulation given at a dose of 2.25 mg/m2 with no dose cap during
Cycle 1 and Marqibo formulation given at 2.25 mg/m2 with no dose cap during Cycle 2.
Both formulations of vincristine sulfate LIPOSOME injection will be administered via a 60
(±10) minute IV infusion.
Blood samples for PK evaluation will be drawn at the following time points: immediately
before infusion, 0.5 hour after the start of the infusion, 0.5 hour after the end of infusion
(EOI), and 3, 8, 15, 24, 48, 72, and 96 hours post-EOI.
In addition to Marqibo or VSLI-RTU, all patients will receive standard doses (per
institutional or regional guidelines) of cyclophosphamide, prednisone, and doxorubicin, (and
rituximab if patient is on the R-CHOP regimen), on Day 1 and prednisone (or prednisolone if
consistent with institutional or regional guidelines) on Days 2 to 5.
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