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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00414089

Enrollment

Registered

2006-12-21

Start date

Unknown

Completion date

Unknown

Last updated

2016-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Brief summary

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.

Interventions

DRUG90Y-ibritumomab tiuxetan (Zevalin)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Response	—

Secondary

Measure	Time frame
Progression free survival	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026