Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

This study has been terminated.

(slow accrual)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT00608517

First received: January 31, 2008

Last updated: May 12, 2014

Last verified: May 2012

History of Changes

Results First Received: October 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes
Interventions:	Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Radiation: total-body irradiation

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 = 9/23/2005 through 8/15/2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 7 people signed consent to take part in this study. Of those, 1 was determined to be ineligible.

Reporting Groups

	Description
Pediatric Myeloablative Conditioning	Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Adult Myeloablative Conditioning	Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Reduced-intensity Conditioning	Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.

Participant Flow: Overall Study

	Pediatric Myeloablative Conditioning	Adult Myeloablative Conditioning	Reduced-intensity Conditioning
STARTED	2	3	1
COMPLETED	1	3	1
NOT COMPLETED	1	0	0
Death	1	0	0

Baseline Characteristics

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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.
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Reporting Groups

	Description
Pediatric Myeloablative Conditioning	Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Adult Myeloablative Conditioning	Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Reduced-intensity Conditioning	Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Total	Total of all reporting groups

Baseline Measures

	Pediatric Myeloablative Conditioning	Adult Myeloablative Conditioning	Reduced-intensity Conditioning	Total
Number of Participants [units: participants]	2	3	1	6
Age [units: participants]
<=18 years	2	0	0	2
Between 18 and 65 years	0	3	1	4
>=65 years	0	0	0	0
Age [units: years] Mean (Standard Deviation)	8 (1)	31 (1)	42 (1)	31 (1)
Gender [units: participants]
Female	1	1	1	3
Male	1	2	0	3
Region of Enrollment [units: participants]
United States	2	3	1	6

Outcome Measures

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1. Primary:

Number of Participants With 100-day Non-relapse Mortality [ Time Frame: 100 days ]

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2. Secondary:

Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells [ Time Frame: 42 days ]

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3. Secondary:

Number of Participants With Acute Graft-versus-host Disease (GVHD) [ Time Frame: 100 days ]

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4. Secondary:

Number of Participants Who Relapsed at 1 Year [ Time Frame: 1 year ]

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5. Secondary:

Number of Subjects With All-cause Mortality [ Time Frame: at 100 days ]

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6. Secondary:

Overall Survival [ Time Frame: 1 year ]

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7. Secondary:

Number of Participants With Chronic Graft Versus Host Disease (GVHD) [ Time Frame: 100 days ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

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

Results Point of Contact:

Name/Title: Brian Engelhardt, M.D.
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-1803

Responsible Party:	Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00608517 History of Changes
Obsolete Identifiers:	NCT00244036
Other Study ID Numbers:	VICC BMT 0552 VU-VICC-BMT-0552
Study First Received:	January 31, 2008
Results First Received:	October 11, 2010
Last Updated:	May 12, 2014
Health Authority:	United States: Food and Drug Administration

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