Clinical trial · Interventional
Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma
A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Non-Hodgkin Lymphoma | Adult Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ONTOLOGY_EXACT | 0.98 |
| Nodal Marginal Zone Lymphoma | Nodal Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Grade 1 Follicular Lymphoma | Grade 1 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 2 Follicular Lymphoma | Grade 2 Follicular Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Grade 3 Follicular Lymphoma |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Agatolimod Sodium | Drug | — | UNRESOLVED |
| Indium In-111 Ibritumomab Tiuxetan | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Radionuclide Imaging | Procedure | — | UNRESOLVED |
| Rituximab | Biological | Rituximab | ALIAS |
| Single Photon Emission Computed Tomography | Procedure | — | UNRESOLVED |
| Yttrium Y-90 Ibritumomab Tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- See Detailed Description
- interventionNames
- Drug: Agatolimod Sodium
- Radiation: Indium In-111 Ibritumomab Tiuxetan
- Other: Laboratory Biomarker Analysis
- Procedure: Radionuclide Imaging
- Biological: Rituximab
- Procedure: Single Photon Emission Computed Tomography
- Radiation: Yttrium Y-90 Ibritumomab Tiuxetan
Primary outcomes (2)
- measure
- Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level
- timeFrame
- at least 10 weeks post treatment up to 3 months.
- description
- Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following: * Absolute neutrophil counts or platelet counts below 10\*10\^9/L for 14 days * Absolute neutrophil counts greater than 0.5 or less than 1\*10\^9/L * Platelet counts greater than 10 or less than 50\*10\^9/L for 28 days. * Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 5000/mm\^3 only for patients with small lymphocytic lymphoma * HGB \>= 8 * Biopsy-proven relapsed, refractory, or residual CD20+ non-Hodgkin's lymphomas; previous biopsies =\<6 months prior to treatment on this protocol will be acceptable as long as there has not been intervening therapy; if the patient has received therapy for NHL between the time of the last biopsy and this protocol, then a re-biopsy is necessary * ECOG performance status (PS) 0, 1, or 2 * Expected survival \>= 3 months * Willingness to provide all biologic specimens as required by the protocol * Total bilirubin =\< 2 x ULN mg/dL (if abnormal, direct bilirubin =\< 1.5 x ULN) Exclusion Criteria: * Prior myeloablative therapies with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support * Prior radioimmunotherapy including Y-90 Zevalin or 131-Iodine anti-B1 antibody or Lym-1 * Presence of CNS lymphoma * Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives * Major surgery other than diagnostic surgery =\< 4 weeks prior to registration * Another active primary malignancy * Known HAMA/HACA (Human anti-mouse or anti-chimeric antibodies) * Myelodysplastic syndrome or marrow chromosomal changes suggesting myelodysplasia * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, abstinence, etc.) * Failed stem cell collection * Marrow cellularity =\< 15% (as determined on all bone marrow samples) * Known to have lymphoma related to HIV or AIDS (these patients are excluded because it is unknown what effects prolonged B-cell depletion will have on these patient's immune system) * G-CSF or GM-CSF therapy =\< 1 week prior to study registration (pegylated filgrastim =\< 3 weeks) * Myelosuppressive chemotherapy =\< 3 weeks prior to study registration (=\< 6 weeks if rituximab, nitrosourea, or Mitomycin C) * Skin rash (such as Stevens-Johnson's syndrome or toxic epidermal necrolysis) with prior rituximab therapy should not be entered on this study because of the risk of reoccurrence of that skin toxicity * Abnormal renal function (serum creatinine \> 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
References
Publications (0)
Data not yet available