Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (HCT)

Stopped early · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, Hodgkin Disease

In brief

For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using cells from a healthy donor represents potentially curative treatment. In these individuals, cure is possible because transplantation of healthy donor immune cells can fight the lymphoma in the patient. The goal of this work is to test a strategy that activates the healthy donor immune cells so that they more effectively fight lymphoma and can result in an increased cure rate for these patients. Our group has previously studied CpG, an immune activating medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now have a more potent form of CpG which we intend to test to see if it will better activate the donor immune cells and result in shrinkage of tumor throughout the entire body, not just at the injected site.

Key facts

Study ID

NCT01745354

Run by

Robert Lowsky

People needed

6

Starts

2012-08-01

Expected to finish

2014-11-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section 3.2.1 for excluded subtypes)
• At least 3 sites of disease
• One for diagnosis (lymph node or bone marrow biopsy)
• One palpable for treatment
• One measurable radiographically
• > 60 days after RIC allogeneic transplant for lymphoma
• 18 years of age or older
• Mixed (5-95%) or complete (>95%) chimerism
• Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2
• ANC >1000/mm3, platelets >50,000/mm3
• Total bilirubin ≤ 2.5 mg/dL, AST and ALT < 3 times upper limit of normal
• Serum creatinine ≤ 3 mg/dL
• No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment
• Minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤ 200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment

You may not qualify if…

• HIV associated lymphoma
• Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)
• Active infection within 14 days prior to scheduled treatment
• Active Cytomegalovirus (CMV) disease at the time of enrollment
• Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
• Pregnant

Where it is running

• Stanford University School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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