Trial Outcomes & Findings for Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma (NCT NCT01549886)
NCT ID: NCT01549886
Last Updated: 2021-10-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
6 Months
Results posted on
2021-10-04
Participant Flow
Participant milestones
| Measure |
MGD+Rituximab+Y-90-Zevalin
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Y-90-Zevalin
Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
MGD+Rituximab+Y-90-Zevalin
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Y-90-Zevalin
Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
|
|---|---|---|
|
Overall Study
Sponsor's decision
|
2
|
3
|
Baseline Characteristics
Phase 2 Study of Zevalin Versus Zevalin and Motexafin Gadolinium in Patients With Rituximab-Refractory Low-grade or Follicular B-cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
MGD+Rituximab+Zevalin
n=2 Participants
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m\^2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Zevalin
n=3 Participants
Day 1 Rituximab 250 mg/m\^2 intravenous infusion. Day 8 Rituximab 250 mg/m\^2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
57 years
STANDARD_DEVIATION 6.24 • n=7 Participants
|
54 years
STANDARD_DEVIATION 4.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Data for this outcome measure was not collected and analysed as no participants available for analysis and study was discontinued prematurely due to business reasons.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 Months and 6 MonthsPopulation: Data for this outcome measure was not collected and analysed as no participants available for analysis and study was discontinued prematurely due to business reasons.
Complete response rate within 3 months, overall response rate within 6 months and progression-free survival.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From time of dosing until 2 yearsPopulation: Safety analysis population.
An Adverse Events (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Non-SAEs was an AE events that are not Serious Adverse Events.
Outcome measures
| Measure |
MGD+Rituximab+Y-90-Zevalin
n=2 Participants
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Y-90-Zevalin
n=3 Participants
Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
Zevalin Regimen: Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
|
|---|---|---|
|
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Serious Adverse Events
|
1 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events
Non-Serious Adverse Events
|
2 Participants
|
3 Participants
|
Adverse Events
MGD+Rituximab+Y-90-Zevalin
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Rituximab+Y-90-Zevalin
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MGD+Rituximab+Y-90-Zevalin
n=2 participants at risk
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Y-90-Zevalin
n=3 participants at risk
Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
Zevalin Regimen: Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • AEs were collected from time of dosing until 2 years.
|
33.3%
1/3 • Number of events 1 • AEs were collected from time of dosing until 2 years.
|
|
Infections and infestations
UTI
|
0.00%
0/2 • AEs were collected from time of dosing until 2 years.
|
33.3%
1/3 • Number of events 1 • AEs were collected from time of dosing until 2 years.
|
|
Investigations
Thrombocytopenia
|
50.0%
1/2 • Number of events 1 • AEs were collected from time of dosing until 2 years.
|
0.00%
0/3 • AEs were collected from time of dosing until 2 years.
|
Other adverse events
| Measure |
MGD+Rituximab+Y-90-Zevalin
n=2 participants at risk
Moxtezafin Gadolinium: Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m2 intravenous infusion.
Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 8 only) by Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.
|
Rituximab+Y-90-Zevalin
n=3 participants at risk
Day 1 Rituximab 250 mg/m2 intravenous infusion. Day 8 Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push (0.3 mCi/kg in patients with a platelet count in 100,000/μL to 149,000/μL.)
Zevalin Regimen: Day 1 - Rituximab 250 mg/m2 intravenous infusion. Day 8 - Rituximab 250 mg/m2 intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
100.0%
2/2 • Number of events 2 • AEs were collected from time of dosing until 2 years.
|
0.00%
0/3 • AEs were collected from time of dosing until 2 years.
|
|
Investigations
Neutrophils count decreased
|
0.00%
0/2 • AEs were collected from time of dosing until 2 years.
|
100.0%
3/3 • Number of events 3 • AEs were collected from time of dosing until 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place