Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL

AHS Cancer Control Alberta

Status and phase: Withdrawn; Phase 2

Conditions: Lymphoma

Treatments: Drug: 90Y-ibritumomab tiuxetan (Zevalin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00414089

HE-10-0100

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)