Clinical trial · Interventional
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
NCT00414089CI-TRIAL-00020924withdrawnPhase 2ClinicalTrials.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): Funding will not be provided for the drug
Summary
Brief summary (as posted)
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Y-ibritumomab tiuxetan (Zevalin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response
Secondary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed indolent lymphoma including: * follicular grade 1 or 2 * small lymphocytic * marginal zone (nodal) * marginal zone (splenic) * mucosa associated lymphoid tissue (MALT) * no evidence of transformation * Stage III or IV disease * No prior therapy * involvement by less than 25% of bone marrow on assessment of trephine biopsy * absolute lymphocyte count ≤ x 109/L * platelets ≥ 150 x 109/L * hemoglobin ≥ 100g/L * absolute neutrophil count ≥ 1.5 x 109/L * at least one bidimensionally measurable lesion at least 2cm by CT scanning Exclusion Criteria: * any other anticancer treatment for NHL * prior radiation therapy * prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant) * no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix * presence of central nervous system lymphoma * patients known to be HIV positive * patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment * patients with abnormal liver function: total bilirubin \> 1.5X ULN or ALT \> 2.5X ULN * patients with abnormal renal function: serum creatinine \> 2.5X ULN * known hypersensitivity to murine antibodies or proteins * immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
References
Publications (0)
Data not yet available
No reference posted for this study.