Trial Outcomes & Findings for Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS) (NCT NCT00480987)

Results Overview

Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10\^9/Liters or more and platelet count of 100\*10\^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100\*10\^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts \>/= 50% and not more than 6-25% abnormal cells in the marrow.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

27 participants

Primary outcome timeframe

After 2 months

Results posted on

2012-08-07

Participant Flow

Recruitment Period 1/15/08 - 11/3/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

There were 27 participants registered and all were included in the analysis. The trial terminated early.

Participant milestones

Participant milestones
Measure	Oxaliplatin + Cytarabine + Fludarabine Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxaliplatin, Fludarabine, and Cytarabine in Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin + Cytarabine + Fludarabine n=27 Participants Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6
Age Continuous	58 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: After 2 months

Population: Analysis was per protocol. All participants treated were analyzed.

Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10\^9/Liters or more and platelet count of 100\*10\^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100\*10\^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts \>/= 50% and not more than 6-25% abnormal cells in the marrow.

Outcome measures

Outcome measures
Measure	Oxaliplatin + Cytarabine + Fludarabine n=27 Participants Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6
Number of Participants With Objective Response Complete response	3 Participants
Number of Participants With Objective Response Complete response with platelets	2 Participants
Number of Participants With Objective Response Partial response	0 Participants

Adverse Events

Oxaliplatin + Cytarabine + Fludarabine

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin + Cytarabine + Fludarabine n=27 participants at risk Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6
Infections and infestations Pneumonia	7.4% 2/27 • Number of events 2 • 2 years
General disorders Death	18.5% 5/27 • Number of events 5 • 2 years

Other adverse events

Other adverse events
Measure	Oxaliplatin + Cytarabine + Fludarabine n=27 participants at risk Oxaliplatin 30 mg/m\^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m\^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m\^2 IV days 2-6
Gastrointestinal disorders Diarrhea	14.8% 4/27 • Number of events 4 • 2 years
Hepatobiliary disorders Hyperbilirubinemia	11.1% 3/27 • Number of events 3 • 2 years
Hepatobiliary disorders Elevated aspartate aminotransferase	11.1% 3/27 • Number of events 3 • 2 years

Additional Information

Gautam Borthakur, MBBS / Assistant Professor

The University of Texas M. D. Anderson Cancer Center

Phone: 713-792-7305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place