Trial Outcomes & Findings for Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant (NCT NCT01083706)

NCT ID: NCT01083706

Last Updated: 2017-05-24

Results Overview

Count of surviving participants at 6 months.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-05-24

Participant Flow

Participant milestones

Measure	Treatment (Chemotherapy) Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

Baseline characteristics by cohort

Measure	Treatment (Chemotherapy) n=39 Participants Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Count of surviving participants at 6 months.

Outcome measures

Measure	Treatment (Chemotherapy) n=39 Participants Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Overall Survival	25 Participants

SECONDARY outcome

Timeframe: 6 months

Count of participants achieving a complete or partial remission at 6 months.

Outcome measures

Measure	Treatment (Chemotherapy) n=39 Participants Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Rate of Response by IWG Criteria	12 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Treatment (Chemotherapy) n=39 Participants Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Incidence of Grades II-IV Graft-versus-host Disease (GVHD)	25 Participants

Adverse Events

Treatment (Chemotherapy)

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Chemotherapy) n=39 participants at risk Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Hospital Admission for Hypoxia	2.6% 1/39 • Number of events 1
Cardiac disorders Hospital Admission for Cardioplumonary Arrest	2.6% 1/39 • Number of events 1
Vascular disorders Hospital Admission for Cardioplumonary Arrest	2.6% 1/39 • Number of events 1

Other adverse events

Measure	Treatment (Chemotherapy) n=39 participants at risk Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. azacitidine: Given SC or IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Thrombocytopenia	12.8% 5/39 • Number of events 11
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 3/39 • Number of events 3
Infections and infestations Infection- Rhizopus Pneumonia	5.1% 2/39 • Number of events 2
Blood and lymphatic system disorders Neutropenia	5.1% 2/39 • Number of events 3
Blood and lymphatic system disorders Anemia	5.1% 2/39 • Number of events 4
Metabolism and nutrition disorders Hypomagnesium	5.1% 2/39 • Number of events 3
Metabolism and nutrition disorders Elevated Billirubin	5.1% 2/39 • Number of events 2

Additional Information

Bart Scott

Fred Hutchinson Cancer Research Center

Phone: 206-667-1990

Email: bscott@fredhutch.org

Results disclosure agreements

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