NCT02337478

Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

An Open Label, Phase II Study of the Feasibility and Efficacy of Vincristine Sulfate Liposome Injection in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase II trial studies how well vincristine sulfate liposome works in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liposomal encapsulation prolongs bioavailability (proportion of drug that enters the circulation when introduced into the body) of vincristine sulfate, and may increase its delivery to cancer cells with fewer side effects.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of administering vincristine sulfate liposome injection (VSLI) to relapsed or refractory acute myeloid leukemia (AML) patients having failed, refused or not a candidate for at least one chemotherapy salvage regimen. II. To observe the hematologic improvement-rate of VSLI in this patient population. SECONDARY OBJECTIVES: I. To observe the overall survival of patients treated with VSLI. II. To observe the response rate (complete remission \[CR\], complete remission with incomplete count recovery \[CRi\], partial response \[PR\], and morphologic leukemia free state \[MLFS\]) of VSLI in this patient population. OUTLINE: Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 6 months.

Conditions

• Recurrent Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Vincristine Sulfate Liposome	Given via injection
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2015-06-05
• Primary completion: 2016-03-31
• Completion: 2017-09-04
• First posted: 2015-01-13
• Last updated: 2019-08-14
• Results posted: 2019-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study