Phase 2
N=38
Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma
Adult Non-Hodgkin Lymphoma · Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue · Nodal Marginal Zone Lymphoma · Recurrent Adult Diffuse Large Cell Lymphoma · Recurrent Grade 1 Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00438880 ↗Enrolled (actual)
38
Serious AEs
50.0%
Results posted
Sep 2014
Primary outcome: Primary: Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level — 0; 1; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Agatolimod Sodium (Drug); Indium In-111 Ibritumomab Tiuxetan (Radiation); Laboratory Biomarker Analysis (Other); Radionuclide Imaging (Procedure); Rituximab (Biological); Single Photon Emission Computed Tomography (Procedure); Yttrium Y-90 Ibritumomab Tiuxetan (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level |
0; 1; 0; 1 | — |
| PRIMARY Tumor Response |
1; 0 | — |
| SECONDARY Progression-free Survival |
1.57 | — |
| SECONDARY Duration of Response |
— | — |
Summary
RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.
Eligibility Criteria
Inclusion Criteria
- The following histologic types by REAL classification and International Working Formulation (IWF) when applicable (NOTE: Closed to accrual as of 10/29/07): Small lymphocytic lymphoma; Lymphoplasmacytoid lymphoma; Follicular center lymphoma, follicular grades 1, 2, and 3; Extranodal marginal zone B cell lymphoma of MALT type; Nodal marginal zone B cell lymphoma
- The following histologic types by REAL classification and International Working Formulation (IWF) when applicable: Diffuse large cell; Transformed lymphoma
- Less than 25% bone marrow involvement of cellular marrow with lymphoma as determined by bilateral bone marrow aspirate and biopsy (the percent involvement should be estimated by the hematopathologist using all of the biopsy material)
- There is no limit on the number of prior therapies (patients who have previously received rituximab are eligible)
- Bi-dimensionally measurable disease: The patients must have >= 1 lesion that has a single diameter of >= 2 cm
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 150,000
- Total lymphocyte count = 8
- Biopsy-proven relapsed, refractory, or residual CD20+ non-Hodgkin's lymphomas; previous biopsies = = 3 months
- Willingness to provide all biologic specimens as required by the protocol
- Total bilirubin = 2 mg/dL)
- Pre-existent clinical autoimmune or antibody mediated diseases, including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia (patients that have no clinical symptoms of these diseases, but merely have previously detected antibodies are eligible)
- Received prior external beam radiation therapy to > 25% of active bone marrow
- Corticosteroid therapy at the time the patient enters the protocol; patients using prednisone or its equivalent for adrenal failure or using < 20mg of prednisone/day for other benign causes are accepted
Data sourced from ClinicalTrials.gov (NCT00438880). 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.