Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Talon Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT00144963

First received: September 1, 2005

Last updated: May 11, 2012

Last verified: December 2011

Results First Received: May 11, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acute Lymphoblastic Leukemia
Interventions:	Drug: Vincristine Sulfate Liposomes Injection Drug: Dexamethasone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
VSLI	Vincristine Sulfate Liposomes Injection (VSLI)

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
VSLI	Vincristine Sulfate Liposomes Injection (VSLI)

Baseline Measures

	VSLI
Number of Participants [units: participants]	36
Age [units: participants]
<=18 years	0
Between 18 and 65 years	33
>=65 years	3
Age [units: years] Mean ± Standard Deviation	36.3 ± 13.83
Gender [units: participants]
Female	12
Male	24
Region of Enrollment [units: participants]
United States	36

Outcome Measures

1. Primary:

MTD of VSLI [ Time Frame: 6 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information