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Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (HCT)
Not Recruiting
Trial ID: NCT01745354
Purpose
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.
Official Title
Intratumoral Injection of an Immunostimulatory CpG, SD-101, Combined With Local Radiation for the Treatment of Recurrent or Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation
Stanford Investigator(s)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Richard Hoppe
Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology
Eligibility
Inclusion Criteria:
- Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section
3.2.1 for excluded subtypes)
- At least 3 sites of disease
1. One for diagnosis (lymph node or bone marrow biopsy)
2. One palpable for treatment
3. 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
Exclusion Criteria:
- 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
Intervention(s):
radiation: Local Radiation
drug: SD-101
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Physician Referrals
650-723-0822