Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease

This study has been completed.

Study NCT00267085 Information provided by M.D. Anderson Cancer Center

First Received on December 19, 2005. Last Updated on January 28, 2011 History of Changes

Results First Received: September 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Myeloid Leukemia Minimal Residual Disease
Intervention:	Biological: Synthetic Tumor-Specific Breakpoint Peptide Vaccine

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
Recruitment Period 12/2/05 to 7/1/08. All participants registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eleven participants were registered, one was excluded from study enrollment and did not receive the Chronic Myeloid Leukemia (CML) Vaccine.

Reporting Groups

	Description
CML Vaccine	Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months

Participant Flow: Overall Study

	CML Vaccine
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
CML Vaccine	Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months

Baseline Measures

	CML Vaccine
Number of Participants [units: participants]	10
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	0
Age [units: years] Median ( Full Range )	45 ( 28 to 63 )
Gender [units: participants]
Female	4
Male	6
Region of Enrollment [units: participants]
United States	10

Outcome Measures

1. Primary:

Response: One Log Decrease in BCR-ABL [ Time Frame: 12 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Jorge Cortes M.D./Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/794-5783
e-mail: eharriso@mdanderson.org

No publications provided

Responsible Party:	Jorge Cortes M.D./Professor, The University of Texas M. D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00267085 History of Changes
Obsolete Identifiers:	NCT00392600
Other Study ID Numbers:	2005-0392
Study First Received:	December 19, 2005
Results First Received:	September 24, 2009
Last Updated:	January 28, 2011
Health Authority:	United States: Food and Drug Administration