Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	Talon Therapeutics, Inc
Collaborator:	Parexel
Information provided by (Responsible Party):	Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00495079

Purpose

This is a clinical research study of an experimental new medication, Marqibo® (vincristine sulfate liposomes injection). The medication Marqibo is experimental and has not been approved for public use. Hana Biosciences, Inc., the company that is developing Marqibo, is the sponsor of this research study. Vincristine sulfate injection is an approved chemotherapy medication that has been used for many years to treat different types of cancer, including leukemias (cancers of the white blood cells). It damages the cancer cells through its effect on microtubulins that are essential during cell division. Marqibo is a liposomal formulation of vincristine sulfate injection. In this formulation, vincristine is placed inside of oil droplets called liposomes. The liposomal formulation results in a slow, steady release of vincristine, exposing the cancer cells to vincristine continuously over specified time.

This study is a Phase 2 study. The main purposes of this study are to:

Show if Marqibo is effective in reducing the growth of ALL in second relapse or in ALL that has returned after two different chemotherapy treatments?
Assess and define the tolerability and the side effects of Marqibo in ALL.

Approximately 56 patients with ALL in second relapse or ALL that has returned after two different chemotherapy treatments will take part in this study at multiple clinical centers.

Condition	Intervention	Phase
Acute Lymphoblastic Leukemia	Drug: Marqibo® (vincristine sulfate liposomes injection)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome tetrasomy 18p

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Vincristine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by Talon Therapeutics, Inc:

Primary Outcome Measures:

Complete remission plus complete remission without full platelet recovery [ Time Frame: Every 28 days ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	May 2007
Study Completion Date:	March 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Patients enrolled will receive Marqibo dose intravenously every 7 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Eligibility Criteria:

Age ≥18 years.
Patients with Philadelphia chromosome-negative ALL in second relapse, or patients with Philadelphia-chromosome-negative ALL who failed two treatment lines of anti-leukemia chemotherapy.
Burkitt's lymphoma is excluded.
Histologically proven ALL and ≥10% bone marrow blasts. Diagnostic material of the screening bone marrow aspirate and biopsy must be submitted to the central hematopathologist.
Responsive to a prior anti-leukemia therapy as defined by a leukemia-free interval of ≥3 months.
ECOG performance status 0-3.
No active CNS disease. History of treated CNS disease is allowable.
Systemic corticosteroids must have been tapered off, preferably before the start of study treatment, but no later than by Day 5 of Course 1. From Day 6 of Course 1 on through the end of study participation, systemic corticosteroids are not allowed, unless the patient shows disease progression or disease relapse, is discontinued from the study treatment, and requires subsequent anti-leukemia therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495079

Show 33 Study Locations

Sponsors and Collaborators

Talon Therapeutics, Inc

Parexel

Investigators

Principal Investigator:

Susan O'Brien, MD

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00495079 History of Changes
Other Study ID Numbers:	HBS407
Study First Received:	June 28, 2007
Last Updated:	September 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Talon Therapeutics, Inc:

acute
lymphoblastic
lymphocytic
leukemia
leukaemia
lukemia
leukimia
ALL
Marqibo
Hana Biosciences
vincristine

liposomal
liposome
optisome
hematology
malignancy
hematological
relapsed
anti-leukemia
adult
chemotherapy

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic

Chromosome Aberrations
Pathologic Processes
Vincristine
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012