Trial Outcomes & Findings for Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma (NCT NCT01497275)
NCT ID: NCT01497275
Last Updated: 2015-07-15
Results Overview
Disease will be assessed every 3 months. The Cheson criteria will be used to define response: Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy. Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
TERMINATED
PHASE2
5 participants
3 months
2015-07-15
Participant Flow
Recruitment started April, 2012 and closed to accrual May, 2014. Patients were recruited from the Cellular Therapy clinic at Duke.
Participant milestones
| Measure |
Zevalin + Velcade
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Zevalin + Velcade
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Zevalin + Velcade
n=5 Participants
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Age, Customized
18-49 Years
|
1 participants
n=5 Participants
|
|
Age, Customized
50-59 Years
|
1 participants
n=5 Participants
|
|
Age, Customized
60-69 Years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Only 3 subjects completed the drug regimen; 1 subject did not complete due to disease progression; 1 did not complete due to adverse event.
Disease will be assessed every 3 months. The Cheson criteria will be used to define response: Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy. Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
Outcome measures
| Measure |
Zevalin + Velcade
n=3 Participants
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Response Rate (Complete Response + Partial Response)
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only 3 subjects provided evaluable data at the 6 month time point. 2 subjects did not reach this time-point so they were not assessed for progression
Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first
Outcome measures
| Measure |
Zevalin + Velcade
n=3 Participants
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Number of Participants With Progression Free Survival
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 1 subject did not reach the one year evaluation because the study was terminated.
Number of participants who were alive at the 1 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)
Outcome measures
| Measure |
Zevalin + Velcade
n=4 Participants
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Overall Survival at 1 Year
|
2 participants
|
SECONDARY outcome
Timeframe: 5 yearPopulation: No analysis completed due to study being terminated prior to the 5 year time point.
Number of participants who were alive at the 5 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)
Outcome measures
Outcome data not reported
Adverse Events
Zevalin + Velcade
Serious adverse events
| Measure |
Zevalin + Velcade
n=5 participants at risk
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
General disorders
other-death
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Zevalin + Velcade
n=5 participants at risk
Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Blurred Vision
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Edema-limbs
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Edema-trunk
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Infusion site extravasation
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Injection site reaction
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
other-herpes zoster
|
20.0%
1/5 • Number of events 1
|
|
Investigations
creatinine increase
|
20.0%
1/5 • Number of events 1
|
|
Investigations
neutrophil count decreased
|
20.0%
1/5 • Number of events 1
|
|
Investigations
platelet count decreased
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in extreminity
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash acne
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
thromboembolic event
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place