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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (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
Overall Participants Analyzed; [Units: Participants]	1
Age; [Units: Participants]; Count of Participants
<=18 years	1 100.0%
Between 18 and 65 years	0 0.0%
>=65 years	0 0.0%
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	1 100.0%
Male	0 0.0%
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 )
First Submitted:	February 6, 2008
First Posted:	February 7, 2008
Results First Submitted:	November 22, 2011
Results First Posted:	March 2, 2012
Last Update Posted:	December 28, 2017