Trial Search Results

Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma

This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: rituximab
  • Drug: bendamustine hydrochloride
  • Drug: bortezomib
  • Drug: lenalidomide

Phase:

Phase 2

Eligibility


DISEASE CHARACTERISTICS:

   - Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin
   lymphoma with no evidence of transformation to large cell histology

      - Patients having both diffuse and follicular architectural elements are eligible
      if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional
      area) and there is no evidence of transformation to a large cell histology

      - Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy)
      required if the interval since tissue diagnosis of low-grade malignant lymphoma
      is > 24 months

         - Bone marrow biopsy alone not acceptable

   - Stage II, III, or IV AND grade 1, 2, or 3a disease

   - Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe
   D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma
   international prognostic index (FLIPI) as defined below:

      - Patient must meet ≥ 1 of the following GELF criteria:

         - Nodal or extranodal mass ≥ 7 cm

         - At least 3 nodal masses > 3.0 cm in diameter

         - Systemic symptoms due to lymphoma or B symptoms

         - Splenomegaly with spleen > 16 cm by CT scan

         - Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal)
         or pleural or peritoneal serous effusion due to lymphoma (irrespective of
         cell content)

         - Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular
         cells)

         - Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10
         g/dL, and/or platelets < 100 x 10^9/L)

      - Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):

         - Age ≥ 60 years

         - Stage III-IV disease

         - Hemoglobin level < 12 g/dL

         - > 4 nodal areas

         - Serum LDH level above normal

   - At least 1 objective measurable disease parameter

      - Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of
      randomization

      - Measurable disease in the liver is required if the liver is the only site of
      lymphoma

PATIENT CHARACTERISTICS:

   - See Disease Characteristics

   - ECOG performance status 0-2

   - ANC ≥ 1,500/mm³ (includes neutrophils and bands)

   - Platelet count ≥ 100,000/mm³

   - Creatinine ≤ 2.0 mg/dL

   - AST and ALT ≤ 5 x upper limit of normal (ULN)

   - Alkaline phosphatase ≤ 5 x ULN

   - Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the
   study PI)

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use 2 effective methods (1 highly effective and 1 additional
   effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after
   completing study treatment

   - HIV-positive patients must meet all of the following criteria:

      - HIV is sensitive to antiretroviral therapy

      - Must be willing to take effective antiretroviral therapy if indicated

      - No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis

      - No history of AIDS-defining conditions

      - If on antiretroviral therapy, must not be taking zidovudine or stavudine

      - Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP)
      during therapy and ≥ 2 months following completion of study therapy or until the
      CD4 cells recover to over 250 cells/mm³

   - No recent history of malignancy except for adequately treated basal cell or squamous
   cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
   been disease-free for ≥ 2 years

   - No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

   - No ≥ grade 2 neuropathy

   - No myocardial infarction within the past 6 months

   - No NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled
   ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
   conduction system abnormalities

   - No serious medical or psychiatric illness likely to interfere with participation in
   this clinical study

   - No known hypersensitivity to boron or mannitol

   - No chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen
   (HBsAg +)

      - Patients with a prior history of HBV infection, but immune, with only IgG
      hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis
      (e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout
      induction and continuation therapy and for ≥ 12 months after the last rituximab
      dose

   - Must register into the mandatory RevAssist® program and be willing and able to comply
   with the requirements of RevAssist® (for patients randomized to arm III)

PRIOR CONCURRENT THERAPY:

   - No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma

      - Prednisone or other corticosteroids used for non-lymphomatous conditions will not
      be considered as prior chemotherapy

      - A prior/recent short course (< 2 weeks) of steroids for symptom relief of
      lymphoma-related symptoms is allowed

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting