Phase 2
Completed N=31
Zevalin (Ibritumomab Tiuxetan) for Early Stage Indolent Lymphomas
Source: ClinicalTrials.gov NCT00493467 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Sep 2020
Primary outcomePrimary: Overall Response Rate (ORR) — 67.7; 29.0; 3.3 Percentage of Participants
Summary
The goal of this clinical research study is to find out if giving (Rituxan) rituximab with 90Y (ibritumomab tiuxetan) (90 Y Zevalin®) may be effective in treating low-grade lymphoma. The safety of this combination treatment will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
67.7; 29.0; 3.3 | — |
| SECONDARY Progression Free Survival (PFS) Rate at 3 Years |
0.62; 0.89 | — |
Eligibility Criteria
Inclusion Criteria
- New diagnosis of low-grade indolent lymphomas Stage I-II. Patients with multiple skin lesions will be eligible provided that the skin is the only site of involvement.
- Histology includes Indolent cluster of differentiation antigen 20 (CD20)+ lymphomas including: Follicular lymphoma, Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells), and Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
- Signed Informed Consent.
- Age >/= 18 years.
- Pre-study Zubrod performance status of 0, 1, or 2.
- Acceptable hematologic status within two weeks prior to patient registration, including: absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1, 500/mm^3, total lymphocyte count /= 100,000/mm^3.
- Female patients who are not pregnant or lactating.
- Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
- Patients determined to have /= 1.5 cm in a single dimension. Measurable cutaneous lesions are allowed.
Exclusion Criteria
- Presence of central nervous system (CNS) lymphoma.
- Patients with HIV or AIDS-related lymphoma.
- Patients with pleural effusion.
- Patients with abnormal liver function: total bilirubin > 2.0 mg/dL.
- Patients with abnormal renal function: serum creatinine > 2.0 mg/dL.
- Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional).
- Impaired bone marrow reserve as indicated by < 15% bone marrow cellularity
- Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- Evidence of transformation in the latest biopsy.
Data sourced from ClinicalTrials.gov (NCT00493467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.