Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)

This study has been completed.

Study NCT00795886 Information provided by University of Utah

First Received on November 19, 2008. Last Updated on April 10, 2012 History of Changes

Results First Received: March 1, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acute Lymphoblastic Leukemia
Intervention:	Drug: RAPAMYCIN

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
Patients were recruited between Aug 2003 and Aug 2008 from 4 pediatric centers in the United States. (Childrens Hospital of Philadelphia; Methodist Childrens Hospital of South Texas (San Antonio); Primary Childrens Medical Center (Salt Lake City); and Childrens Hospital of Pittsburgh.

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
Rapamycin	This includes all study participants.

Participant Flow: Overall Study

	Rapamycin
STARTED	63
COMPLETED	53
NOT COMPLETED	10
Death	10

Baseline Characteristics

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Reporting Groups

	Description
Rapamycin	This includes all study participants.

Baseline Measures

	Rapamycin
Number of Participants [units: participants]	63
Age [units: participants]
<=18 years	61
Between 18 and 65 years	2
>=65 years	0
Age [units: years] Mean ± Standard Deviation	9.9 ± 5.3
Gender [units: participants]
Female	25
Male	38
Region of Enrollment [units: participants]
United States	63

Outcome Measures

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1. Primary:

Number of Participants With Transplant-related Mortality [ Time Frame: 24 months after transplant ]

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2. Primary:

Two Year Overall Survival [ Time Frame: 24 months after transplant ]

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3. Secondary:

Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD) [ Time Frame: 180 days ]

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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:

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

There is NOT 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.

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: Michael Pulsipher, MD
Organization: Primary Children's Medical Center
phone: 801-662-4732
e-mail: Michael.Pulsipher@hsc.utah.edu

No publications provided

Responsible Party:	University of Utah
ClinicalTrials.gov Identifier:	NCT00795886 History of Changes
Other Study ID Numbers:	HCI # 14044
Study First Received:	November 19, 2008
Results First Received:	March 1, 2011
Last Updated:	April 10, 2012
Health Authority:	United States: Institutional Review Board