Trial Outcomes & Findings for Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage (NCT NCT00890656)
NCT ID: NCT00890656
Last Updated: 2012-02-20
Results Overview
Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 \* 10\^9/L and a platelet count of ≥ 100 \* 10\^9/L with complete resolution of all sites of extramedullary disease required.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.
Results posted on
2012-02-20
Participant Flow
Recruitment Period: 6/9/2003 to 10/12/2009. All patients registered at The University of Texas M.D. Anderson Cancer Center.
Participant milestones
| Measure |
Augmented Hyper-CVAD
Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
Baseline characteristics by cohort
| Measure |
Augmented Hyper-CVAD
n=90 Participants
Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
|
|---|---|
|
Age Continuous
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 \* 10\^9/L and a platelet count of ≥ 100 \* 10\^9/L with complete resolution of all sites of extramedullary disease required.
Outcome measures
| Measure |
Augmented Hyper-CVAD
n=90 Participants
Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
|
|---|---|
|
Number of Participants With Complete Remission
|
41 Participants
|
Adverse Events
Augmented Hyper-CVAD
Serious events: 33 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Augmented Hyper-CVAD
n=90 participants at risk
Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
|
|---|---|
|
Infections and infestations
Neutropenic fever
|
8.9%
8/90 • Number of events 8 • 7 years, 7 months
|
|
General disorders
Death
|
10.0%
9/90 • Number of events 9 • 7 years, 7 months
|
|
Infections and infestations
Infection
|
23.3%
21/90 • Number of events 21 • 7 years, 7 months
|
|
General disorders
Pain
|
6.7%
6/90 • Number of events 6 • 7 years, 7 months
|
|
Cardiac disorders
Cardiac other
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
Renal and urinary disorders
Cystitis
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
General disorders
Allergic reaction
|
2.2%
2/90 • Number of events 2 • 7 years, 7 months
|
|
Cardiac disorders
Hypotension
|
14.4%
13/90 • Number of events 13 • 7 years, 7 months
|
|
Nervous system disorders
Syncope
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
Eye disorders
Visual loss
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
General disorders
fever
|
4.4%
4/90 • Number of events 4 • 7 years, 7 months
|
|
Gastrointestinal disorders
GI hemmorrhage
|
2.2%
2/90 • Number of events 2 • 7 years, 7 months
|
|
Gastrointestinal disorders
Dehydration
|
2.2%
2/90 • Number of events 2 • 7 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/90 • Number of events 1 • 7 years, 7 months
|
Other adverse events
| Measure |
Augmented Hyper-CVAD
n=90 participants at risk
Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
|
|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
35.6%
32/90 • Number of events 32 • 7 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.6%
23/90 • Number of events 23 • 7 years, 7 months
|
|
Nervous system disorders
Neuropathy
|
14.4%
13/90 • Number of events 13 • 7 years, 7 months
|
|
Endocrine disorders
hyperglycemia
|
18.9%
17/90 • Number of events 17 • 7 years, 7 months
|
|
Hepatobiliary disorders
Elevated liver function tests
|
32.2%
29/90 • Number of events 29 • 7 years, 7 months
|
|
General disorders
Pain
|
5.6%
5/90 • Number of events 5 • 7 years, 7 months
|
|
Gastrointestinal disorders
Mucositis
|
21.1%
19/90 • Number of events 19 • 7 years, 7 months
|
Additional Information
Stefan Fader, M.D./Associate Professor
The University of Texas M. D. Anderson Cancer Center
Phone: 713/745-4613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place