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Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266147
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief Summary:
To assess the safety and tolerability of escalating doses of SD-101 in combination with localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Drug: SD-101 Radiation: Radiation therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: SD-101 in combination with low-dose radiation

PART 1

  • Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1
  • COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
  • COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29
  • COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29
  • COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29

PART 2

Cycle 1: Required

  • Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1
  • COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29
  • COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Cycle 2: Optional

  • Radiation: 2 fractions of 2 Gy over 2 days at Days 180 and 181
  • COHORT 1: 1 mg/mL at Days 181, 188, 195, 202, and 209
  • COHORT 2: 8 mg/mL at Days 181, 188, 195, 202, and 209
Drug: SD-101
Radiation: Radiation therapy



Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities (DLTs), injection-site reactions (ISRs), adverse events (AEs), and serious adverse events (SAEs). [ Time Frame: DLTs and ISRs evaluated through 7 days after last dose (Day 36); AEs evaluated through Day 90; SAEs evaluated for up to 2 years. ]
  2. Changes in interferon (IFN)-inducible genes [ Time Frame: Evaluated through Day 9 ]

Secondary Outcome Measures :
  1. Response rate of treated tumor according to Cheson criteria [ Time Frame: Up to 2 years ]
  2. Response rate of untreated tumor according to Cheson criteria [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5151
United States, Illinois
Northwestern University
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
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
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Study Director: Abraham Leung, MD Dynavax Technologies Corporation
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Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02266147    
Other Study ID Numbers: DV3-LYM-01
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dynavax Technologies Corporation:
Low Grade B-cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin