Trial Outcomes & Findings for Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) (NCT NCT00656617)
NCT ID: NCT00656617
Last Updated: 2015-03-09
Results Overview
Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
PFS Evaluation at 7 months
Results posted on
2015-03-09
Participant Flow
Recruitment Period: All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Of the 106 participants enrolled, three participants completed the study's first run-in induction portion then another 103 participants were enrolled for the second portion of combined drug induction and maintenance. Four of those 103 enrolled participants were not treated.
Participant milestones
| Measure |
Idarubicin + Ara-C + Vorinostat
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
Run-in Induction Phase
|
3
|
|
Overall Study
Induction Phase
|
103
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Idarubicin + Ara-C + Vorinostat
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
Insurance Issues
|
2
|
|
Overall Study
Move to different clinical trial
|
2
|
Baseline Characteristics
Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Idarubicin + Ara-C + Vorinostat
n=106 Participants
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PFS Evaluation at 7 monthsPopulation: Four (4) participants did not receive treatment therefore were not evaluable for outcome assessment.
Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
Outcome measures
| Measure |
Idarubicin + Ara-C + Vorinostat
n=102 Participants
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|
|
Progression Free Survival (PFS) at 7 Months
|
65 percentage of participants
|
SECONDARY outcome
Timeframe: Monitoring with each 4 week cycle, up to 18 cycles of treatmentPopulation: Four (4) participants were not treated therefore not evaluable for the outcome assessment.
Number of participants with response assessed according RECIST: Complete Response (CR) defined as normalization of marrow (\< 5% blasts) and of peripheral blood counts (neutrophil count \> 1.109/L, platelet count \> 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by \>50% compared to pretreatment values but above \<5%. Complete Response without platelet recovery (CRp) = CR, but platelets \<100 x 109/L. Progressive disease (PD) defined as increase of blasts to \> 10% after an initial response.
Outcome measures
| Measure |
Idarubicin + Ara-C + Vorinostat
n=102 Participants
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|
|
Participant Response
Complete Response (CR)
|
67 participants
|
|
Participant Response
Partial Response (PR)
|
0 participants
|
|
Participant Response
Complete Response without platelet recovery (CRp)
|
11 participants
|
|
Participant Response
Progressive Disease (PD)
|
0 participants
|
|
Participant Response
No response
|
24 participants
|
Adverse Events
Idarubicin + Ara-C + Vorinostat (Phase 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Idarubicin + Ara-C + Vorinostat (Phase 2)
Serious events: 3 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idarubicin + Ara-C + Vorinostat (Phase 1)
n=3 participants at risk
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
Idarubicin + Ara-C + Vorinostat (Phase 2)
n=99 participants at risk
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory, Other
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
Other adverse events
| Measure |
Idarubicin + Ara-C + Vorinostat (Phase 1)
n=3 participants at risk
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
Idarubicin + Ara-C + Vorinostat (Phase 2)
n=99 participants at risk
Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
|
|---|---|---|
|
Infections and infestations
Opportunistic infection associated with Grade 2 or more Lymphopenia
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
29.3%
29/99 • Number of events 31 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Cardiac Arrhythmia-Other (Specify)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
6.1%
6/99 • Number of events 6 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Ventricular arrhythmia--Select
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Cardiac General-Other (Specify)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
5.1%
5/99 • Number of events 5 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, Other disorders
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
3.0%
3/99 • Number of events 3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
31.3%
31/99 • Number of events 32 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
3.0%
3/99 • Number of events 3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
3/3 • Number of events 3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
71.7%
71/99 • Number of events 81 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
9.1%
9/99 • Number of events 9 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
18.2%
18/99 • Number of events 20 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Hemorrhage, CNS
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Hemorrhage, GI--Select
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
5.1%
5/99 • Number of events 5 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Hemorrhage, GU--Select
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
5.1%
5/99 • Number of events 7 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
6.1%
6/99 • Number of events 7 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Infections and infestations
Febrile neutropenia (fever unknown origin without clinical/microbiological documented infection)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
67.7%
67/99 • Number of events 111 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Infections and infestations
Infection (documented clinical/microbiologically), Grade 3-4 neutrophils
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Infections and infestations
Infection
|
100.0%
3/3 • Number of events 4 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
4.0%
4/99 • Number of events 4 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
3.0%
3/99 • Number of events 3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase) -
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
12.1%
12/99 • Number of events 16 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
12.1%
12/99 • Number of events 13 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Nervous system disorders
Mental status
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
3.0%
3/99 • Number of events 3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Eye disorders
Scleral necrosis/melt
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
General disorders
Pain-Other
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
6.1%
6/99 • Number of events 9 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
2.0%
2/99 • Number of events 2 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/3 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
4.0%
4/99 • Number of events 4 • Adverse event (AE) data collected while participants received study drugs up to 18 cycles (4-6 week cycles). Overall study period: 4/15/08 to 4/15/13. Four of the study's second group were not treated and therefore excluded from AE reporting.
|
Additional Information
Guillermo Garcia-Manero, MD/Professor, Leukemia Department
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-3428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place