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

NCT01745354 | Terminated Phase 1 DMC

• 3 other identifiers: BMT235SU-07212011-812920741
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Outcome Measures

Primary Outcomes (1)

• Determination of the maximum tolerated dose based on dose limiting toxicity defined as any new grade 3-4 toxicity after the first SD-101 administration

  60 Days

Secondary Outcomes (3)

• Measure cytotoxic T-cell activity changes pre- and post-treatment of tumor infiltrating lymphocytes and peripheral blood lymphocytes using ELISA and Immunohistochemistry.

  2, 3, 8 weeks after treatment

• Measure tumor response by PET-CT scan imaging

  8 weeks after treatment

• Measure level of donor specific tumor infiltrating lymphocytes by flow cytometry and Immunofluorescence

  2, 3, 8 weeks after treatment

Study Arms (1)

SD-101 + Combined with Local Radiation

EXPERIMENTAL

Drug: SD-101; Radiation: Local Radiation

Interventions

SD-101 DRUG

SD-101 will be administered after radiation to only the largest palpable lymph node as an intratumoral injection weekly for 3 weeks at three dosing cohorts: 0.3 mg, 1 mg, and 3 mg

Also known as: Dynavax

SD-101 + Combined with Local Radiation

Local Radiation RADIATION

SD-101 + Combined with Local Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Robert Lowsky: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert Lowsky

  Stanford University

  PRINCIPAL INVESTIGATOR

• Lauren Maeda

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 18, 2016

Record last verified: 2015-11

Locations

US (1)