Clinical trial · Interventional
Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.
Phase III,Open-label,Prospective,Two-armed,Multicenter Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.
NCT00322218CI-TRIAL-00056018terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to low recruitment rate that would have led to a long study duration.
Summary
Brief summary (as posted)
This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zevalin | Drug | Ibritumomab Tiuxetan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zevalin
- description
- Patients received Zevalin. Zevalin Therapeutic Regimen: Day 1: Initial administration of 250 mg/m\^2 rituximab, followed immediately by administration of 185 MBq of \[111In\]-ibritumomab tiuxetan ,in centers where centers where biodistribution imaging or dosimetry had not been required, the first rituximab infusion was given alone. \- Day 7-9: Rituximab 250 mg/m\^2, followed immediately by \[90Y\]-ibritumomab tiuxetan 14.8 MBq/kg given as a slow intravenous push over 10 minutes. Two treatment days one week apart were followed by a 12-week safety period.
- interventionNames
- Drug: Zevalin
- type
- NO_INTERVENTION
- label
- Observational
- description
- Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse. This was non-interventional Stage consisting of a longterm follow-up period (until completion of a median observation period of 5 years).
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, Ann Arbor stage II, III, or IV Diffuse large B-cell lymphoma (DLBCL) according to the Revised European American Lymphoma(REAL)/World Health Organization (WHO) classification . * Central pathology review confirming the DLBCL diagnosis and Cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow * First-line treatment of DLBCL must have been 6 or 8 cycles of standard CHOP chemotherapy in combination with rituximab . * Complete remission(CR) or unconfirmed complete remission(CRu) according to the International Workshop Response Criteria for Non Hodgkins Lymphoma (NHL) described by Cheson et al and modified for this study after first-line treatment with CHOP-R. Computerised Tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of CHOP-R. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis (pre-CHOP-R). * Central radiographic review of the CT scans from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu * Patients 60 years of age or older at time of randomization * WHO performance status (PS) of 0 to 2 within 1 week of randomization * Absolute neutrophil count greater than or equal to 1.5 x 10\^9/L within 1 week of randomization * Hemoglobin greater than or equal to 10 g/dL within 1 week of randomization * Platelets greater than or equal to 150 x 10\^9/L within 1 week of randomization * Life expectancy of 3 months or longer * Written informed consent obtained according to local guidelines Exclusion Criteria: * Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma * Prior radioimmunotherapy, radiation therapy, or any other NHL therapy except first-line CHOP-R * Presence of gastric, central nervous system or testicular lymphoma at first diagnosis * Histological transformation of low-grade non-Hodgkin's lymphoma (NHL) * Known seropositivity for hepatitis C virus or hepatitis B surface antigen * Known history of Human Immunodeficiency virus (HIV) infection * Abnormal liver function: total bilirubin \> 1.5 x upper limit of normal (ULN) or Alanine Aminotransferase \> 2.5 x ULN within 1 week of randomization * Abnormal renal function: serum creatinine \> 2.0 x ULN within 1 week of randomization * Nonrecovery from the toxic effects of CHOP-R therapy * Known hypersensitivity to murine or chimeric antibodies or proteins * Granulocyte Colony Stimulating Factor (G-CSF) or Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling * 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) which could compromise participation in the study * Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment * Female patients who are pregnant or are currently breastfeeding * Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy * Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery * Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment * Unwillingness or inability to comply with the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.