Trial Outcomes & Findings for Zevalin-beam for Aggressive Lymphoma (NCT NCT00491491)
NCT ID: NCT00491491
Last Updated: 2020-08-31
Results Overview
actuarial 2 year survival
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
2 years after transplantation
Results posted on
2020-08-31
Participant Flow
Participant milestones
| Measure |
Z-BEAM
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=22 Participants
|
20 Participants
n=21 Participants
|
41 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=43 Participants
|
|
Age, Continuous
|
58 years
n=22 Participants
|
51 years
n=21 Participants
|
55 years
n=43 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=22 Participants
|
11 Participants
n=21 Participants
|
27 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=22 Participants
|
10 Participants
n=21 Participants
|
16 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
22 participants
n=22 Participants • Study stopped early due to slow accrual
|
21 participants
n=21 Participants • Study stopped early due to slow accrual
|
43 participants
n=43 Participants • Study stopped early due to slow accrual
|
PRIMARY outcome
Timeframe: 2 years after transplantationactuarial 2 year survival
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Overall Survival
|
91 percentage of participants
Interval 79.0 to 100.0
|
62 percentage of participants
Interval 39.0 to 85.0
|
SECONDARY outcome
Timeframe: 2 years after transplantationactuarial 2-year PFS
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Progression-free Survival
|
59 percentage of PARTICIPANTS
Interval 39.0 to 80.0
|
37 percentage of PARTICIPANTS
Interval 14.0 to 60.0
|
SECONDARY outcome
Timeframe: 100 days after transplantationcomplete response (CR) and partial response (PR) proportion at day 100,
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Clinical Response
|
22 participants
|
20 participants
|
SECONDARY outcome
Timeframe: 100 days after transplantationtime to hematopoietic recovery
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Hematopoietic Recovery
|
10 DAYS
Interval 7.0 to 21.0
|
11 DAYS
Interval 10.0 to 17.0
|
SECONDARY outcome
Timeframe: 100 days after transplantationincidence of infection, grade III-IV toxicities, treatment-related mortality
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Grade III Toxicity
grade III toxicity
|
3 Participants
|
4 Participants
|
|
Grade III Toxicity
infection
|
6 Participants
|
1 Participants
|
|
Grade III Toxicity
none
|
13 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 5 years after transplantationincidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).
Outcome measures
| Measure |
Z-BEAM
n=22 Participants
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 Participants
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Secondary Malignancies
|
0 Participants
|
0 Participants
|
Adverse Events
Z-BEAM
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard BEAM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Z-BEAM
n=22 participants at risk
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 participants at risk
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Infections and infestations
JC virus encephalitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
Z-BEAM
n=22 participants at risk
ibritumomab tiuxetan (zevalin) BEAM
ibritumomab tiuxetan: 0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantation
|
Standard BEAM
n=21 participants at risk
standard BEAM chemotherapy
BEAM chemotherapy and autologous stem-cell transplantation
|
|---|---|---|
|
Infections and infestations
infection
|
27.3%
6/22 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place