Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

This study has been terminated.

(Low accrual)

Sponsor:

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT00609739

First received: February 6, 2008

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Results First Received: November 22, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Leukemia
Interventions:	Drug: cyclosporine Drug: cytarabine Drug: filgrastim Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Procedure: allogeneic bone marrow transplantation Procedure: umbilical cord blood transplantation Drug: Cis-Retinoic acid

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
Only 1 patient was enrolled (yr 1999) and later died (yr 2000). Study was terminated due to low accrual.

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
Cytarabine + Mitoxantrone	Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.

Participant Flow: Overall Study

	Cytarabine + Mitoxantrone
STARTED	1
COMPLETED	1
NOT COMPLETED	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
Cytarabine + Mitoxantrone	Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.

Baseline Measures

	Cytarabine + Mitoxantrone
Number of Participants [units: participants]	1
Age [units: years]
<=18 years	1
Between 18 and 65 years	0
>=65 years	0
Gender [units: participants]
Female	1
Male	0
Region of Enrollment [units: participants]
United States	1

Outcome Measures

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1. Primary:

Disease-free Survival [ Time Frame: 1 year ]

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2. Secondary:

Patients With Regimen-Related Toxicity [ Time Frame: Up to 30 Days Post Study Treatment ]

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3. Secondary:

Patients With Graft-Versus-Host-Disease [ Time Frame: Up to 30 Days Post Study Treatment ]

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4. Secondary:

Patients Who Relapsed [ Time Frame: 1 Year ]

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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
Only 1 patient was enrolled (yr 1999) and later died (yr 2000). Study was terminated due to low accrual.

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: Margaret MacMillan, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-2778
e-mail: macmi002@umn.edu

Responsible Party:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00609739 History of Changes
Other Study ID Numbers:	1999LS032 UMN-MT1999-08 ( Other Identifier: Blood and Marrow Transplantation Program ) 9906M07303 ( Other Identifier: IRB, University of Minnesota )
Study First Received:	February 6, 2008
Results First Received:	November 22, 2011
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration

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