Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02266147|
Recruitment Status : Terminated (The sponsor terminated the trial early because there was sufficient data to make a decision about SD-101 in the lymphoma development program.)
First Posted : October 16, 2014
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
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|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma||Drug: SD-101 Radiation: Radiation therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2, Non-randomized, Open-label, Multicenter, Dose Escalation and Expansion Study of Intratumoral Injections of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: SD-101 in combination with low-dose radiation
Cycle 1: Required
Cycle 2: Optional
Radiation: Radiation therapy
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD). [ Time Frame: Up to Day 36 ]
- Number of Participants Experiencing Injection-site Reactions (ISRs) [ Time Frame: Up to Day 36 ]Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain
- Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 38 weeks ]
- Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB) [ Time Frame: Change from Day 8 to Day 9 ]Fold change of IFN-responsive gene expression relative to Day 8
- Number of Participants With Preliminary Response - Local (Injected Lesions) [ Time Frame: Up to 38 weeks ]Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
- Number of Participants With Preliminary Response - Systemic (Non-injected Lesions) [ Time Frame: Up to 38 weeks ]Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Biopsy confirmed, untreated, low-grade B-cell lymphoma, including follicular (Grade 1, 2, or 3A) [Harris, Swerdlow et al. 2008] or marginal, or CLL/SLL with lymph node involvement.
- At least 2 sites of measurable disease per Cheson criteria (must measure at least 1.5 cm in any diameter or 1.0 cm in the shortest diameter if one of the diameters is not ≥ 1.5 cm), one of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection (denoted as "Lesion A" in Treatment Cycle 1) and at least one additional untreated lesion that is located outside the radiation field of the treated lesion (Lesion A) and is accessible for an FNA aspirate.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Aged 18 years and older
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count > 100,000/µL
- Serum creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN).
- Serum total bilirubin ≤ 1.5 x the ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- International normalized ratio or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy and the PT or partial thromboplastin time (PTT) must be within the therapeutic range of the intended use of anticoagulants.
- Activated PTT (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, and the PT or PTT is within therapeutic range of intended use of anticoagulants.
- Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication if of childbearing potential as defined in this protocol. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable method of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), cooper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
- Ability to understand and sign informed consent form (ICF) and comply with treatment protocol
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment.
- Positive for hepatitis B (HBsAg reactive), HCV ribonucleic acid (RNA) qualitative, or human immunodeficiency virus (HIV)( HIV 1/2 antibodies)
- Diagnosis of mantle or diffuse large-cell lymphoma, Grade 3B follicular lymphoma [Harris, Swerdlow et al. 2008] or gastric mucosa-associated lymphoid tissue (MALT) lymphoma
- Clinically significant pleural effusion
- Active infection including cytomegalovirus
- Pregnant or breast feeding within the projected duration of trial participation through 4 months after the last dose of study treatment.
- Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjӧgren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
- Lymphoma involvement of the central nervous system
- Received any prior therapy for lymphoma
- Use of any investigational agent within the last 28 days
- Serious, non-healing wound, ulcer, or bone fracture.
- If a subject received major surgery, must have recovered adequately from the toxicity and/or complications from the intervention prior to enrollment.
- Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day -1 (Visit 1); Grade II or greater peripheral vascular disease at study entry
- Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study
- History of sensitivity to any component of SD-101
- A diagnosis of cancer within the last 3 years prior to enrollment or any known additional malignancy that is progressing or requires active treatment. Exceptions are B-cell lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
- Is taking systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266147
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305-5151|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Study Director:||Abraham Leung, MD||Dynavax Technologies Corporation|
Documents provided by Dynavax Technologies Corporation:
|Responsible Party:||Dynavax Technologies Corporation|
|Other Study ID Numbers:||
|First Posted:||October 16, 2014 Key Record Dates|
|Results First Posted:||September 4, 2020|
|Last Update Posted:||September 4, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Low Grade B-cell Lymphoma
Neoplasms by Histologic Type
Immune System Diseases