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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Principal Investigator

Andrew Belch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

HE-10-0100

NCT ID:

NCT00414089

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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