Trial Outcomes & Findings for Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS) (NCT NCT01019317)
NCT ID: NCT01019317
Last Updated: 2016-03-15
Results Overview
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
COMPLETED
PHASE2
151 participants
Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)
2016-03-15
Participant Flow
Recruitment Period: 11/23/2009 through 10/25/2010. All participants recruited at UT MD Anderson Cancer Center.
Of the 151 participants enrolled, four (4) participants were excluded from the trial before treatment.
Participant milestones
| Measure |
Cytarabine + Fludarabine
Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
|
|---|---|
|
Overall Study
STARTED
|
151
|
|
Overall Study
COMPLETED
|
147
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Cytarabine + Fludarabine
Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
|
|---|---|
|
Overall Study
Not Eligible
|
4
|
Baseline Characteristics
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Baseline characteristics by cohort
| Measure |
Cytarabine + Fludarabine
n=151 Participants
Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
|
|---|---|
|
Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)Population: Of participants enrolled, 147 participants received treatment and were evaluable.
Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Outcome measures
| Measure |
Cytarabine + Fludarabine
n=147 Participants
Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
|
|---|---|
|
Participants With a Complete Response
|
34 Participants
|
Adverse Events
Cytarabine + Fludarabine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cytarabine + Fludarabine
n=147 participants at risk
Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
23.1%
34/147 • Number of events 34 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
12/147 • Number of events 12 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
20/147 • Number of events 20 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Gastrointestinal disorders
Mucositis
|
12.2%
18/147 • Number of events 18 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
15/147 • Number of events 15 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Hepatobiliary disorders
Elevated Liver Function
|
10.9%
16/147 • Number of events 16 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
|
Infections and infestations
Infection
|
53.1%
78/147 • Number of events 78 • Two years, ten months.
Of the 151 participants registered, four did not recieve treatment and were excluded from adverse event reporting.
|
Additional Information
Elias Joseph Jabbour MD/Assistant Professor
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place