Trial Outcomes & Findings for Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab (NCT NCT00850499)
NCT ID: NCT00850499
Last Updated: 2012-12-12
Results Overview
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to 8 cycles (1 cycle is 35 days: 280 days)
Results posted on
2012-12-12
Participant Flow
Participant milestones
| Measure |
Velcade + Fludarabine
|
Rituximab + Fludarabine
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
1
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Velcade + Fludarabine
|
Rituximab + Fludarabine
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Baseline characteristics by cohort
| Measure |
Velcade + Fludarabine
n=4 Participants
|
Rituximab + Fludarabine
n=8 Participants
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age Continuous
|
61.3 years
STANDARD_DEVIATION 12.84 • n=93 Participants
|
60.0 years
STANDARD_DEVIATION 10.06 • n=4 Participants
|
60.4 years
STANDARD_DEVIATION 10.47 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=93 Participants
|
3 participants
n=4 Participants
|
4 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 8 cycles (1 cycle is 35 days: 280 days)Population: Received at least one dose of study drug
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
Outcome measures
| Measure |
Velcade + Fludarabine
n=4 Participants
Velcade + Fludarabine
|
Rituximab + Fludarabine
n=8 Participants
Rituximab + Fludarabine
|
|---|---|---|
|
Complete Response Rate
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 8 cycles (1 cycle is 35 days: 280 days)Population: Received at least one dose of study drug
The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Outcome measures
| Measure |
Velcade + Fludarabine
n=4 Participants
Velcade + Fludarabine
|
Rituximab + Fludarabine
n=8 Participants
Rituximab + Fludarabine
|
|---|---|---|
|
Overall Response Rate
|
3 participants
|
6 participants
|
Adverse Events
Velcade + Fludarabine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Rituximab + Fludarabine
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Velcade + Fludarabine
n=4 participants at risk
|
Rituximab + Fludarabine
n=8 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
25.0%
1/4
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dypnoea
|
0.00%
0/4
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4
|
12.5%
1/8
|
|
General disorders
General physical health deterioration
|
0.00%
0/4
|
12.5%
1/8
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory gas exchange disorder
|
0.00%
0/4
|
12.5%
1/8
|
Other adverse events
| Measure |
Velcade + Fludarabine
n=4 participants at risk
|
Rituximab + Fludarabine
n=8 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4
|
25.0%
2/8
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4
|
25.0%
2/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4
|
50.0%
4/8
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4
|
37.5%
3/8
|
|
Eye disorders
Blepharitis
|
25.0%
1/4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
25.0%
1/4
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4
|
12.5%
1/8
|
|
General disorders
Asthenia
|
25.0%
1/4
|
37.5%
3/8
|
|
General disorders
Fatigue
|
0.00%
0/4
|
25.0%
2/8
|
|
General disorders
Oedema peripheral
|
0.00%
0/4
|
12.5%
1/8
|
|
General disorders
Performance status decreased
|
0.00%
0/4
|
12.5%
1/8
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4
|
12.5%
1/8
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4
|
12.5%
1/8
|
|
Infections and infestations
Tinea infection
|
0.00%
0/4
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4
|
12.5%
1/8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4
|
0.00%
0/8
|
|
Psychiatric disorders
Conversion disorder
|
25.0%
1/4
|
0.00%
0/8
|
|
Psychiatric disorders
Depression
|
25.0%
1/4
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/4
|
12.5%
1/8
|
Additional Information
Andrew Cakana, MD, FRC Path
Johnson & Johnson Pharmaceutical Research & Development
Email: [[email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place