A Phase 3 interventional study of Zevalin and Y-90-Zevalin in Diffuse Large B-cell Lymphoma and Follicle Center Lymphoma, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 93 sites in 13 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Spectrum Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.
5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.
This study's enrollment of 79 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Spectrum Pharmaceuticals, Inc is the lead sponsor of 59 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received rituximab 250 milligram per meter square (mg/m\^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m\^2 by 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 participants with a platelet count in 100,000/ microliter \[μL\] to 149,000/μL).
Drug: Zevalin · Drug: Y-90-Zevalin · Drug: Rituximab · Drug: In-111 Zevalin
Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease.
Zevalin administered intravenous infusion.
Also known as: Ibritumomab Tiuxetan
Y-90-Zevalin administered by intravenous infusion.
Rituximab administered by intravenous infusion.
In-111-Zevalin administered by intravenously.
Overall Survival (OS) for Living Participants
OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Overall Survival for Death
OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Progression-Free Survival (PFS)
PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.
Time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)
Overall Survival Rate at 24 Months
The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.
Time frame: 24 Months
A total of 79 participants were enrolled into the study from 19 Apr 2012 to 23 Oct 2014.
| Milestone | Zevalin | Observation |
|---|---|---|
| Started | 36 | 43 |
| Completed | 6 | 8 |
| Not completed | 30 | 35 |
| Withdrew: Sponsor discretion | 28 | 28 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 4 |
| Withdrew: Other | 0 | 1 |
OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.
| months | Zevalin | Observation |
|---|---|---|
| Overall Survival (OS) for Living Participants | 8.90 (2.73 to 22.60) | 6.14 (0.07 to 21.32) |
OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.
| months | Zevalin | Observation |
|---|---|---|
| Overall Survival for Death | 16.76 (16.76 to 16.76) | 5.82 (1.94 to 9.69) |
PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.
No measurements were reported for this outcome.
The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.
No measurements were reported for this outcome.
Collected over From first dose up to approximately 2.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zevalin | 1/36 (2.8%) | 8/36 (22.2%) | 21/36 (58.3%) |
| Observation | 2/43 (4.7%) | 3/43 (7%) | 7/43 (16.3%) |
| Event | Zevalin | Observation |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 4/36 | 1/43 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/36 | 0/43 |
| Platelet count decreasedInvestigations | 2/36 | 0/43 |
| DeathGeneral disorders | 0/36 | 2/43 |
| LeukopeniaBlood and lymphatic system disorders | 1/36 | 0/43 |
| Lung infectionInfections and infestations | 1/36 | 0/43 |
| Lymphocyte count decreasedInvestigations | 1/36 | 0/43 |
| SyncopeNervous system disorders | 1/36 | 0/43 |
| HypotensionVascular disorders | 1/36 | 0/43 |
| Depressed level of consciousnessNervous system disorders | 0/36 | 1/43 |
| Event | Zevalin | Observation |
|---|---|---|
| FatigueGeneral disorders | 10/36 | 2/43 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/36 | 0/43 |
| NeutropeniaBlood and lymphatic system disorders | 6/36 | 1/43 |
| Platelet count decreasedInvestigations | 6/36 | 0/43 |
| Neutrophil count decreasedInvestigations | 6/36 | 0/43 |
| White blood cell count decreasedInvestigations | 6/36 | 0/43 |
| AnaemiaBlood and lymphatic system disorders | 5/36 | 0/43 |
| ConstipationGastrointestinal disorders | 5/36 | 0/43 |
| NauseaGastrointestinal disorders | 4/36 | 1/43 |
| Lymphocyte count decreasedInvestigations | 4/36 | 0/43 |
Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.
| Age, Continuous(years) | Zevalin | Observation | Total |
|---|---|---|---|
| Mean | 69 ± 1.02 | 71 ± 1.06 | 70 ± 0.75 |
| Sex: Female, Male(Participants) | Zevalin | Observation | Total |
|---|---|---|---|
| Female | 20 | 22 | 42 |
| Male | 16 | 21 | 37 |
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Spectrum Pharmaceuticals, Inc