Clinical trial · Interventional
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R-CVP) With R-CVP Alone in High-Risk Subjects With Previously Untreated CD20-Positive Follicular Non-Hodgkin's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated early as per the Sponsor's decision.
Summary
Brief summary (as posted)
This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CVP | Drug | — | UNRESOLVED |
| Zevalin Therapeutic Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin).
- interventionNames
- Drug: Zevalin Therapeutic Regimen
- Drug: R-CVP
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Participants will receive standard R-CVP.
- interventionNames
- Drug: R-CVP
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information). * Age greater than or equal to 18 years at the time of informed consent. * Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/World Health Organization (WHO)classification (from initial diagnosis); grades 1, 2, or 3. * Bi-dimensionally measurable lesion(s) in at least one site. * High risk NHL as defined by a follicular lymphoma international prognostic index (FLIPI) of 3, 4, or 5 assessed within 3 months prior to randomization. * NHL requires treatment as determined by the investigator. * Confirmed CD20+ lymphoma cells. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,or 2. * Expected survival of greater than or equal to 3 months. * Male subjects and female subjects of child bearing potential willing to practice effective contraception during the study and willing and able to continue contraception for 1 year after their last dose of study treatment (R CVP for subjects in the observation arm and the Zevalin therapeutic regimen for subjects in the Zevalin arm). Exclusion Criteria: * Previous anticancer treatment for NHL, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy. * Known seropositivity for hepatitis C virus, hepatitis B virus (surface antigen-positive), or other active infection uncontrolled by treatment. * Known diagnosis of human immunodeficiency virus infection. * Presence of primary gastric, central nervous system (CNS), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (CLL). * Active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Abnormal liver function: total bilirubin \>1.5 X upper limit of normal (ULN) or ALT \>2.5 X ULN. * Impairment of renal function (serum creatinine \>1.5 X ULN) not due to lymphoma. * Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study. * Known hypersensitivity to murine and/or chimeric proteins. * History of severe allergic or anaphylactic reactions. * Known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (CVP), or Zevalin. * Treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization. * Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins. * Females with a positive pregnancy test result at screening or who are currently breastfeeding. * Inability to comply with study requirements. * Major surgery within 28 days except for diagnosis. * In need of immediate intervention to treat life threatening complications.
References
Publications (0)
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