Trial Outcomes & Findings for Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation (NCT NCT00609739)

NCT ID: NCT00609739

Last Updated: 2017-12-28

Results Overview

Number of patients who were free of disease and alive at 1 year.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2017-12-28

Participant Flow

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

Participant milestones

Measure	Cytarabine + Mitoxantrone Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cytarabine + Mitoxantrone n=1 Participants Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Number of patients who were free of disease and alive at 1 year.

Outcome measures

Measure	Cytarabine + Mitoxantrone n=1 Participants Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Disease-free Survival	0 Participants

SECONDARY outcome

Timeframe: Up to 30 Days Post Study Treatment

Number of patients with adverse events related to treatment.

Outcome measures

Measure	Cytarabine + Mitoxantrone n=1 Participants Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Patients With Regimen-Related Toxicity	0 participants

SECONDARY outcome

Timeframe: Up to 30 Days Post Study Treatment

Number of patients who exhibited acute and/or chronic graft-versus-host disease.

Outcome measures

Measure	Cytarabine + Mitoxantrone n=1 Participants Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Patients With Graft-Versus-Host-Disease	1 participants

SECONDARY outcome

Timeframe: 1 Year

Number of patients whose disease relapsed.

Outcome measures

Measure	Cytarabine + Mitoxantrone n=1 Participants Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
Patients Who Relapsed	1 participants

Adverse Events

Cytarabine + Mitoxantrone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cytarabine + Mitoxantrone n=1 participants at risk Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
General disorders Death	100.0% 1/1 • Number of events 1 • Up to 30 days post study treatment. Regimen related toxicity (RRT) is a concern, but because of the seriousness of relapsed JMML, a high incidence of grade III and IV RRT will be considered acceptable. No other adverse events were collected.

Other adverse events

Adverse event data not reported

Additional Information

Margaret MacMillan, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-626-2778

Email: macmi002@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place