Trial Outcomes & Findings for Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL (NCT NCT00379574)
NCT ID: NCT00379574
Last Updated: 2013-03-15
Results Overview
All patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
14 weeks
Results posted on
2013-03-15
Participant Flow
Duration of patient enrollment: From 15-Dec-2006 to 02-May-2009
Participant milestones
| Measure |
Bortezomib + CHOP Every 2 Weeks
1. Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5
2. Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
Baseline characteristics by cohort
| Measure |
Bortezomib + CHOP Every 2 Weeks
n=49 Participants
CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
52 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksAll patients,9 patients of phase I study and 40 patietns in phase II stuay, were assessed with International Working Group response criteria assessed by CT; Complete Response (CR), Disappearance of all detectable clinical and radiographic evidence of disease and diappearance of all disease-related symptoms.
Outcome measures
| Measure |
Bortezomib + CHOP Every 2 Weeks
n=49 Participants
CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
|
|---|---|
|
Number of Patients Who Achieved Complete Response
|
32 participants
Interval 65.2 to 89.5
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Bortezomib + CHOP Every 2 Weeks
n=49 Participants
CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
|
|---|---|
|
Number of Patients Who Experienced Adverse Events
|
49 participants
|
Adverse Events
Bortezomib + CHOP Every 2 Weeks
Serious events: 22 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib + CHOP Every 2 Weeks
n=49 participants at risk
CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
4/40 • Number of events 4
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/40
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
4/40 • Number of events 4
|
|
Metabolism and nutrition disorders
fatigue
|
5.0%
2/40 • Number of events 2
|
|
Endocrine disorders
hyperglycemia
|
10.0%
4/40 • Number of events 4
|
|
Gastrointestinal disorders
vomiting
|
10.0%
4/40 • Number of events 4
|
|
Nervous system disorders
sensory neuropathy
|
27.5%
11/40 • Number of events 11
|
|
Nervous system disorders
motor neuropathy
|
7.5%
3/40 • Number of events 3
|
|
Blood and lymphatic system disorders
anemia
|
55.0%
22/40 • Number of events 22
|
|
Blood and lymphatic system disorders
neutropenia
|
35.0%
14/40 • Number of events 14
|
|
Blood and lymphatic system disorders
feberile neutropenia
|
17.5%
7/40 • Number of events 15
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
32.5%
13/40 • Number of events 13
|
Other adverse events
| Measure |
Bortezomib + CHOP Every 2 Weeks
n=49 participants at risk
CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
67.5%
27/40 • Number of events 27
|
|
Gastrointestinal disorders
anorexia
|
62.5%
25/40 • Number of events 26
|
|
Gastrointestinal disorders
constipation
|
57.5%
23/40 • Number of events 24
|
|
Gastrointestinal disorders
diarrhea
|
52.5%
21/40 • Number of events 22
|
|
Metabolism and nutrition disorders
fatigue
|
57.5%
23/40 • Number of events 25
|
|
Gastrointestinal disorders
nausea
|
27.5%
11/40 • Number of events 20
|
|
Gastrointestinal disorders
vomiting
|
40.0%
16/40 • Number of events 20
|
|
Nervous system disorders
sensory neuropathy
|
55.0%
22/40 • Number of events 27
|
|
Nervous system disorders
motor neuropathy
|
42.5%
17/40 • Number of events 21
|
|
Blood and lymphatic system disorders
anemia
|
27.5%
11/40 • Number of events 19
|
|
Blood and lymphatic system disorders
neutropenia
|
30.0%
12/40 • Number of events 15
|
|
Infections and infestations
febrile neutropenia
|
15.0%
6/40 • Number of events 7
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
37.5%
15/40 • Number of events 17
|
Additional Information
Dr. Cheolwon Suh
Asan Medical Center, Ulsan University College of Medicine
Phone: +82-2-3010-3209
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place