Trial Outcomes & Findings for Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML) (NCT NCT00422591)
NCT ID: NCT00422591
Last Updated: 2018-08-23
Results Overview
Complete Response (CR): Normalization of marrow (\< 5% blasts; \>10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count \> 109/L, platelet count \> 100 x 109/L).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Up to 2 months
Results posted on
2018-08-23
Participant Flow
Recruitment Period: 12/2006 to 01/2017
Of the 175 participants registered, six were never treated.
Participant milestones
| Measure |
Idarubicin + Cytarabine
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
COMPLETED
|
169
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Idarubicin + Cytarabine
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Idarubicin + Cytarabine
n=175 Participants
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
156 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
175 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 monthsComplete Response (CR): Normalization of marrow (\< 5% blasts; \>10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count \> 109/L, platelet count \> 100 x 109/L).
Outcome measures
| Measure |
Idarubicin + Cytarabine
n=169 Participants
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Complete Response (CR) Rate
Complete Response
|
98 Participants
|
|
Complete Response (CR) Rate
Partial Response
|
4 Participants
|
|
Complete Response (CR) Rate
Complete Response w/o Platelet Recovery
|
9 Participants
|
|
Complete Response (CR) Rate
Death
|
7 Participants
|
|
Complete Response (CR) Rate
No Response
|
51 Participants
|
SECONDARY outcome
Timeframe: from treatment initiation until treatment failure, relapse, or deathEvent -Free Survival (EFS) EFS was calculated with Kaplan-Meier estimates. Event-free survival (EFS), defined as the time to no response to intensive induction therapy, relapse, or death of any cause, whichever comes first.
Outcome measures
| Measure |
Idarubicin + Cytarabine
n=169 Participants
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Event-Free Survival (EFS)
|
4.7 Months
Interval 1.0 to 72.0
|
SECONDARY outcome
Timeframe: Until death or loss of follow-upOverall Survival (OS) was calculated with Kaplan-Meier estimates. OS was calculated from the time of treatment initiation until death.
Outcome measures
| Measure |
Idarubicin + Cytarabine
n=169 Participants
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Overall Survival (OS)
|
11.3 Months
Interval 1.0 to 75.0
|
Adverse Events
Idarubicin + Cytarabine
Serious events: 77 serious events
Other events: 87 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Idarubicin + Cytarabine
n=169 participants at risk
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Abscess Left Groin
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
General disorders
Abdominal Pain
|
1.8%
3/169 • Number of events 3 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Anemia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Arrythmia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthritis Knee
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
2/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Cardiac Arrest
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Cardiac Infarction
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Catheter Related Infection
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Cellulitis
|
1.2%
2/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Surgical and medical procedures
Cholecyctectomy
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Cholecystitis
|
1.2%
2/169 • Number of events 3 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Colitis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
General disorders
Death
|
5.9%
10/169 • Number of events 10 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
4/169 • Number of events 4 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Edema - leg
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
General disorders
Fever
|
3.6%
6/169 • Number of events 7 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Hemorrhage Gastrointestinal
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Hypotension
|
0.59%
1/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Infection
|
8.3%
14/169 • Number of events 18 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Infection Abcess
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Intracerebral Hemorrhage
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Injury
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Immune system disorders
Myelosupression
|
1.2%
2/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Nervous system disorders
Neuropathy
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Neutropenic Fever
|
16.0%
27/169 • Number of events 34 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Pain Cardiovascular
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
General disorders
Pain Head/Neck
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Pneumonia
|
5.3%
9/169 • Number of events 10 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Pneumonitis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Renal and urinary disorders
Renal Failure
|
1.2%
2/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Nervous system disorders
Seizure
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Sepsis
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Sinus Bradycarida
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Supraventricular arrhythmia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Nervous system disorders
Syncope
|
1.2%
2/169 • Number of events 2 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Wound Infection
|
0.59%
1/169 • Number of events 1 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
Other adverse events
| Measure |
Idarubicin + Cytarabine
n=169 participants at risk
Idarubicin 12 mg/m2 intravenously (IV) over 1 hour daily days 1-3. Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
20/169 • Number of events 20 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
26/169 • Number of events 26 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
10/169 • Number of events 12 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Febrile Neutropenia
|
27.8%
47/169 • Number of events 65 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Infection/unknown ANC
|
11.8%
20/169 • Number of events 28 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Infection other
|
5.9%
10/169 • Number of events 10 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Infections and infestations
Opportunistic Infection
|
10.7%
18/169 • Number of events 19 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
5.9%
10/169 • Number of events 10 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
|
General disorders
Pain
|
4.7%
8/169 • Number of events 8 • Adverse events captured from the time of participant consent and will be followed to resolution or stabilization; up to 1 year.
|
Additional Information
Farhad Ravandi-Kashani, MD
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place