Trial Outcomes & Findings for Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma (NCT NCT00980395)
NCT ID: NCT00980395
Last Updated: 2019-12-30
Results Overview
PFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
2 years
Results posted on
2019-12-30
Participant Flow
Participant milestones
| Measure |
VCR (Velcade, Cladribine and Rituximab)
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma
Baseline characteristics by cohort
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=24 Participants
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Histology
Mantle-cell lymphoma
|
11 Participants
n=5 Participants
|
|
Histology
Follicular lymphoma
|
5 Participants
n=5 Participants
|
|
Histology
Marginal zone lymphoma
|
4 Participants
n=5 Participants
|
|
Histology
Lymphoplasmacytic lymphoma
|
3 Participants
n=5 Participants
|
|
Histology
Small lymphocytic lymphoma
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.
Outcome measures
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=23 Participants
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Progression-free Survival at 2 Years
|
15 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=23 Participants
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Overall Survival at 2 Years
|
18 Participants
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=23 Participants
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Complete Response Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: Two yearsOutcome measures
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=23 Participants
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Partial Response
|
14 Participants
|
Adverse Events
VCR (Velcade, Cladribine and Rituximab)
Serious events: 14 serious events
Other events: 24 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=24 participants at risk
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
6/24 • 107 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.8%
5/24 • 107 months
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
2/24 • 107 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • 107 months
|
Other adverse events
| Measure |
VCR (Velcade, Cladribine and Rituximab)
n=24 participants at risk
* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles
rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.
bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.
cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.
|
|---|---|
|
General disorders
Fatigue
|
79.2%
19/24 • 107 months
|
|
General disorders
Fever
|
16.7%
4/24 • 107 months
|
|
Nervous system disorders
Neuropathy
|
4.2%
1/24 • 107 months
|
Additional Information
Amy Selegue, NCTN Program Coordinator
University of Arizona
Phone: 520-626-0301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place