Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Bendamustine; Rituximab; Y-90 ibritumomab
Intervention description: 90mg/m2, IV - Days 1 and 2 of every cycle; 375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle; 0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to learn about the safety and effectiveness of treating
      follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT)
      using 90-yttrium (Y) ibritumomab tiuxetan.

      The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly
      found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to
      the study treatment.

      Bendamustine is approved by the United States Food and Drug Administration (FDA) for the
      treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL)
      that has progressed during or within six months of treatment with rituximab or a
      rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat
      follicular lymphoma.

      Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or
      follicular, CD20-positive B-cell non-Hodgkin's lymphoma.

      90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or
      refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular
      NHL. It is also approved for the treatment of follicular NHL that is previously untreated
      with radioimmunotherapy and that achieved a partial or complete response to first-line
      chemotherapy.

      Study participants will will receive bendamustine and rituximab for up to 16 weeks. If
      participants' cancer responds well to the treatment with bendamustine and rituximab, they
      will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete,
      participants will be asked to return to the clinic every 3 months for a maximum of 10 years
      for follow-up visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated, histologically confirmed follicular lymphoma classification
             grade 1, 2 or 3a

          -  Ann Arbor stages of II to IV with either symptomatic or bulky disease (>5 cm); or
             disease progression

          -  18 years of age or older

          -  ECOG PS <2

          -  Normal organ and marrow function defined as below:

        Absolute neutrophil count (ANC) >= 1,000/mm3 Platelet count >=100,000/mm3 Patients with ANC
        less than 1,000/mm3 and/or platelets below 100,000/mm3 are still eligible for study entry
        as long as there is >50% bone marrow involvement with lymphoma

          -  Adequate hepatic function

          -  Adequate renal function

          -  Measureable disease with at least one lesion measuring > 2cm in its greatest
             transverse diameter

          -  Female subjects of childbearing potential must have a negative pregnancy test (urine
             or serum b-HCG) at screening and within 1 week prior to the start of treatment with
             Y-90 ibritumomab tiuxetan

          -  Voluntary written informed consent must be given before performance of any
             study-related procedure

        Exclusion Criteria:

          -  Prior chemotherapy, immunotherapy, or monoclonal antibody therapy

          -  Receiving any other investigational agents

          -  Primary CNS lymphoma

          -  Known HIV

          -  Treatment with therapeutic doses of systemic steroids within 4 weeks of beginning
             study treatment (cycle 1, day -7); topical use of corticosteroids and systemic
             replacement of corticosteroids for adrenal insufficiency are allowed

          -  Malignant pleural, pericardial or peritoneal effusions

          -  Known history of myelodysplastic syndrome (MDS) or found to have MDS

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would, in the judgment of
             the investigator, limit compliance with study requirements

          -  Pregnant or lactating female subjects

          -  Concurrent active malignancy other than lymphoma or history of invasive malignancy
             within the past 5 years, except completely excised, non-melanoma skin cancer

          -  Known Hepatitis B and/or Hepatitis C Infection

          -  Any other condition, that in the judgment of the investigator places the patient at
             unacceptable risk if he/she were to participant in the study