Trial Outcomes & Findings for VELCADE,Rituximab,Cyclophosphamide and Decadron (NCT NCT00413959)
NCT ID: NCT00413959
Last Updated: 2018-09-19
Results Overview
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
4 years
Results posted on
2018-09-19
Participant Flow
Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.
Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.
Participant milestones
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Overall Study
Pt had only one cycle.
|
1
|
Baseline Characteristics
VELCADE,Rituximab,Cyclophosphamide and Decadron
Baseline characteristics by cohort
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
n=12 Participants
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: 1 pt withdrew before completing two cycles and was not evaluable for OS.
Percentage of complete responders plus percentage of partial responders equals overall response rate.
Outcome measures
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
n=11 Participants
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
|
90 percentage of patients
|
SECONDARY outcome
Timeframe: 4 yearsThe study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Outcome measures
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
n=11 Participants
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Overall Survival
|
83 percentage of participants
|
Adverse Events
Velcade, Rituximab,Cyclophosphamide & Decadron
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
n=12 participants at risk
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
Cardiac disorders
Congestive Heart Failure
|
8.3%
1/12
|
|
Nervous system disorders
Cerebral Vascular Accident
|
8.3%
1/12
|
Other adverse events
| Measure |
Velcade, Rituximab,Cyclophosphamide & Decadron
n=12 participants at risk
Velcade 375 mg/m\^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
|
|---|---|
|
General disorders
Anxiety Grade 1 & 2
|
16.7%
2/12
|
|
Gastrointestinal disorders
Abdominal Pain Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Appetite Decreased Grade 1 & 2
|
8.3%
1/12
|
|
Renal and urinary disorders
Bilirubin Increased Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Alopecia Grade 1 & 2
|
8.3%
1/12
|
|
Renal and urinary disorders
Creatinine Increased Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation Grade 1 & 2
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Chills Grade 1 & 2
|
16.7%
2/12
|
|
General disorders
Edema Grade 1 & 2
|
16.7%
2/12
|
|
General disorders
Fever Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Fatigue Grade 1 & 2
|
33.3%
4/12
|
|
Gastrointestinal disorders
Hyponatremia Grade 1 & 2
|
8.3%
1/12
|
|
Cardiac disorders
Hypertension Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hyperglycemia Grade 1 & 2
|
16.7%
2/12
|
|
General disorders
Insomnia Grade 1 & 2
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Leukopenia Grade 1 & 2
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Rash Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Nausea Grade 1 & 2
|
25.0%
3/12
|
|
Gastrointestinal disorders
Mucositis Grade 1 & 2
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema Grade 1 & 2
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Nail Changes Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Sweats Grade 1 & 2
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Dry Skin Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Stomatitis Grade 1 & 2
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion Grade 1 & 2
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Tronopin Increased Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Triglyceride Increased Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Tongue Swelling Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Weight Decreased Grade 1 & 2
|
16.7%
2/12
|
|
General disorders
Tooth Abcess Grade 1 & 2
|
8.3%
1/12
|
|
Gastrointestinal disorders
Vomiting Grade 1 & 2
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Difficulty Walking Grade 1 & 2
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Chest Pain Grade 3 & 4
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hyperglycemia Grade 3 & 4
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Leukopenia Grade 3 & 4
|
25.0%
3/12
|
|
Blood and lymphatic system disorders
Neutropenia Grade 3 & 4
|
25.0%
3/12
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea Grade 3 & 4
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema Grade 3 & 4
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli Grade 3 & 4
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath Grade 3 & 4
|
8.3%
1/12
|
|
General disorders
Headache Grade 1 & 2
|
8.3%
1/12
|
|
General disorders
Pain Grade 1 & 2
|
16.7%
2/12
|
Additional Information
Sigrun Hallmeyer, MD Director of Research
Oncology Specialists SC
Phone: 847-268-8200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place