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

History of Changes

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

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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

	VSLI
STARTED	36
COMPLETED	36
NOT COMPLETED	0

Baseline Characteristics

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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 ]

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Measure Type	Primary
Measure Title	MTD of VSLI
Measure Description	Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
Time Frame	6 weeks
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This study was designed to define the MTD of VSLI. Up to 7 sequential escalating dose cohorts (1.5, 1.825, 2.0, 2.25, 2.4, 2.6, and 2.8 mg/m2) were planned, with at least 3 subjects in each cohort. Escalation to the next higher dose cohort was allowed to proceed only if no nonhematologic DLT was observed.

Reporting Groups

	Description
VSLI	Vincristine Sulfate Liposomes Injection (VSLI)

Measured Values

	VSLI
Number of Participants Analyzed [units: participants]	26
MTD of VSLI [units: mg/m2]	2.25

No statistical analysis provided for MTD of VSLI

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: VP, Regulatory Affairs
Organization: Talon Therapeutics
phone: 650-228-5066
e-mail: ttarlow@talontx.com

No publications provided

Responsible Party:	Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00144963 History of Changes
Other Study ID Numbers:	VSLI-06-ALL
Study First Received:	September 1, 2005
Results First Received:	May 11, 2012
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

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