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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-05

Study Completion Date

2017-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia

NCT03851081

Allogeneic Hematopoietic Stem Cell Transplantation Recipient Blasts 5 Percent or More of Bone Marrow Nucleated Cells Blasts 5 Percent or More of Peripheral Blood White Cells +5 more

WITHDRAWN PHASE1/PHASE2

Epigenetic Reprogramming in Relapse AML

NCT02412475

Leukemia, Acute Myeloid

TERMINATED PHASE1

A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS

NCT05424380

Leukemia, Myeloid, Acute

TERMINATED PHASE1

EphB4-HSA Fusion Protein and Cytarabine /or Liposomal Vincristine in Patients With Recurrent or Refractory Acute Leukemia

NCT03519984

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Blasts 5 Percent or More of Bone Marrow Nucleated Cells Myelodysplastic/Myeloproliferative Neoplasm +8 more

TERMINATED PHASE1

Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT01550185

Adult Acute Basophilic Leukemia Adult Acute Eosinophilic Leukemia Adult Acute Megakaryoblastic Leukemia (M7) +14 more

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Adult Acute Myeloid Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (vincristine sulfate liposome)

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.

Group Type EXPERIMENTAL

Vincristine Sulfate Liposome

Intervention Type DRUG

Given via injection

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vincristine Sulfate Liposome

Given via injection

Intervention Type DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

liposomal vincristine Marqibo vincristine liposomal vincristine sulfate liposome injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
* Patients must be ineligible for, refused or having failed at least one previous salvage regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3
* Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
* Fertile men must practice effective contraceptive methods during the study period, unless documentation of infertility exists
* Mentally competent, ability to understand and willingness to sign the informed consent form
* No serious medical illness that would potentially increase patients' risk for toxicity
* No active central nervous system (CNS) disease
* No active uncontrolled bleeding/bleeding diathesis
* No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
* No unwillingness or inability to follow protocol requirements
* No evidence of ongoing, uncontrolled infection
* No requirement for immediate palliative treatment of any kind including surgery
* No option for immediate bone marrow transplant unless patient refuses this therapy
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =\< 3 x upper normal limit (UNL), alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =\< 3 x UNL
* Bilirubin =\< 3 x UNL
* Glomerular filtration rate (GFR) \> 50 ml/min/1.72 m\^2 or creatinine \< 2 g/dL

Exclusion Criteria

* Serious medical illness or severe debilitating pulmonary disease that would potentially increase the patients' risk for toxicity
* Patients with persistent grade 3 or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy
* Patients with active central nervous system (CNS) disease
* Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
* Pregnant women, or women of child-bearing potential not using reliable means of contraception
* Lactating females
* Fertile men unwilling to practice contraceptive methods during the study period
* Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
* Unwilling or unable to follow protocol requirements
* Evidence of ongoing, uncontrolled infection
* Patients with known human immunodeficiency virus (HIV) infection
* Requirement for immediate palliative treatment of any kind including surgery
* Evidence of inadequate hepatic function (aspartate aminotransferase \[AST/SGOT\] =\< 3 x upper normal limit \[UNL\], alanine aminotransferase \[ALT/SGPT\] =\< 3 x UNL \[=\< 5 x ULN if liver metastases present\], bilirubin =\< 1.5 x UNL)
* Evidence of inadequate renal function (creatinine \> 2 g/dL)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No