A Phase 2 interventional study of Rituximab and Ibritumomab Tiuxetan in Marginal Zone Lymphoma, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by University of Miami · Phase 2, Interventional, and Treatment
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Drug: Rituximab · Drug: Ibritumomab Tiuxetan
IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Also known as: Rituxan, IDEC-C2B8, Chimeric anti-CD20 monoclonal antibody
IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9: 0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Also known as: Zevalin
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Time frame: 12 weeks post-therapy
Rate of Progression-Free Survival
The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
Time frame: End of study.
5-Year Rate of Progression-Free Survival (5-Year PFS)
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Time frame: 5 Years
Overall Survival (OS) Rate
The time from the date of initiation of study treatment until date of death from any cause for all participants.
Time frame: End of Study
5 Year Rate of Overall Survival (5-Year OS)
Percentage of participants still alive five years after the date of protocol therapy initiation.
Time frame: 5 Years
Number of Participants With Unacceptable Toxicity.
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Time frame: Up to 12 weeks post-therapy
| Milestone | Zevalin + Rituximab |
|---|---|
| Started | 18 |
| Completed | 16 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
| percentage of participants | Zevalin + Rituximab |
|---|---|
| Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy. | 87.5 (65.6 to 97.7) |
The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
| months | Zevalin + Rituximab |
|---|---|
| Rate of Progression-Free Survival | 47.6 (4.0 to 93.3) |
Percentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
| percentage of participants | Zevalin + Rituximab |
|---|---|
| 5-Year Rate of Progression-Free Survival (5-Year PFS) | 40 (19.9 to 59.5) |
The time from the date of initiation of study treatment until date of death from any cause for all participants.
| months | Zevalin + Rituximab |
|---|---|
| Overall Survival (OS) Rate | NA |
Percentage of participants still alive five years after the date of protocol therapy initiation.
| percentage of participants | Zevalin + Rituximab |
|---|---|
| 5 Year Rate of Overall Survival (5-Year OS) | 71.8 (46.8 to 86.5) |
Number of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
| participants | Zevalin + Rituximab |
|---|---|
| Number of Participants With Unacceptable Toxicity. | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zevalin + Rituximab | — | 2/16 (12.5%) | 15/16 (93.8%) |
| Event | Zevalin + Rituximab |
|---|---|
| Upper Respiratory Infection (Grade 3)Respiratory, thoracic and mediastinal disorders | 1/16 |
| Fatigue (Grade 3)General disorders | 1/16 |
| Abdominal Pain (Grade 3)Gastrointestinal disorders | 1/16 |
| Sepsis (Grade 5)Infections and infestations | 1/16 |
| Event | Zevalin + Rituximab |
|---|---|
| LeukocytesBlood and lymphatic system disorders | 15/16 |
| PlateletsBlood and lymphatic system disorders | 14/16 |
| HemoglobinBlood and lymphatic system disorders | 9/16 |
| NeutrophilsBlood and lymphatic system disorders | 9/16 |
| LymphopeniaBlood and lymphatic system disorders | 8/16 |
| HyperglycemiaMetabolism and nutrition disorders | 7/16 |
| FatigueGeneral disorders | 6/16 |
| FeverGeneral disorders | 6/16 |
| Metabolic/Lab - Other(Specify)Metabolism and nutrition disorders | 6/16 |
| BruisingSkin and subcutaneous tissue disorders | 4/16 |
Data reported for only 16 of 18 participants due to 2 participants withdrawing consent.
| Age, Continuous(years) | Zevalin + Rituximab |
|---|---|
| Median | 62 (55 to 70) |
| Age, Continuous(years) | Zevalin + Rituximab |
|---|---|
| Mean | 62 ± 13 |
| Age, Continuous(years) | Zevalin + Rituximab |
|---|---|
| Mean | 62 (37 to 84) |
| Sex: Female, Male(Participants) | Zevalin + Rituximab |
|---|---|
| Female | 7 |
| Male | 9 |
| Disease Stage(participants) | Zevalin + Rituximab |
|---|---|
| Stage I/II | 3 |
| Stage III/IV | 13 |
| Extranodal disease sites(participants) | Zevalin + Rituximab |
|---|---|
| 0, 1 sites | 11 |
| 2 or more sites | 5 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(participants) | Zevalin + Rituximab |
|---|---|
| 0 | 14 |
| 1 | 2 |
| 2 | 0 |
| Bone Marrow involvement(participants) | Zevalin + Rituximab |
|---|---|
| Yes | 0 |
| No | 16 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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