Trial Outcomes & Findings for Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL (NCT NCT00151320)
NCT ID: NCT00151320
Last Updated: 2018-06-19
Results Overview
Overall Response Rate
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
76 participants
Primary outcome timeframe
6 cycles (18 weeks)
Results posted on
2018-06-19
Participant Flow
Participant milestones
| Measure |
Arm 1
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
Baseline characteristics by cohort
| Measure |
Untreated DLBCL
n=40 Participants
with untreated Diffuse Large B-cell Lymphoma (n = 40)
|
Untreated MCL
n=36 Participants
with untreated mantle cell Non-Hodgkin's Lymphoma
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
66 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 cycles (18 weeks)Overall Response Rate
Outcome measures
| Measure |
Untreated DLBCL
n=40 Participants
with untreated Diffuse Large B-cell Lymphoma (n = 40)
|
Untreated MCL
n=36 Participants
with untreated mantle cell Non-Hodgkin's Lymphoma
|
|---|---|---|
|
ORR
|
88 percentage of patients
|
81 percentage of patients
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=76 participants at risk
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
|
|---|---|
|
Renal and urinary disorders
Uroepithelial carcinoma
|
1.3%
1/76 • Number of events 1
|
Other adverse events
| Measure |
Arm 1
n=76 participants at risk
Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles
Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by a dose escalation schedule.
Bortezomib, CHOP, Rituximab: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)
VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:
Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
55.3%
42/76
|
|
Blood and lymphatic system disorders
Anemia
|
78.9%
60/76
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
77.6%
59/76
|
|
Infections and infestations
Febrile Neutropenia
|
17.1%
13/76
|
|
Infections and infestations
Infection (normal ANC)
|
18.4%
14/76
|
|
Infections and infestations
Sepsis
|
7.9%
6/76
|
|
Nervous system disorders
Neuropathy
|
64.5%
49/76
|
|
Gastrointestinal disorders
Anorexia
|
40.8%
31/76
|
|
General disorders
Nausea
|
43.4%
33/76
|
|
Gastrointestinal disorders
Constipation
|
48.7%
37/76
|
|
Gastrointestinal disorders
Diarrhea
|
32.9%
25/76
|
|
General disorders
Edema
|
23.7%
18/76
|
|
General disorders
Vomiting
|
18.4%
14/76
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.7%
18/76
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.9%
6/76
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonitis
|
2.6%
2/76
|
|
Cardiac disorders
Cardiac Arrhythmia
|
7.9%
6/76
|
|
Cardiac disorders
Congestive heart failure
|
2.6%
2/76
|
|
Renal and urinary disorders
acute renal failure
|
2.6%
2/76
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
2.6%
2/76
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place