TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma
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|ClinicalTrials.gov Identifier: NCT02927964|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3a Follicular Lymphoma Recurrent Follicular Lymphoma Refractory Follicular Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Radiation: Radiation Therapy Drug: TLR9 Agonist SD-101||Phase 1 Phase 2|
I. To determine the recommended phase 2 dose (RP2D) of intratumoral TLR9 agonist SD-101 (SD-101) in combination with ibrutinib and radiation in patients with relapsed or refractory low-grade follicular lymphoma. (Phase Ib) II. To determine the safety and tolerability of SD-101 in combination with ibrutinib and radiation in patients with relapsed or refractory low-grade follicular lymphoma. (Phase Ib) III. To evaluate the efficacy of intratumoral SD-101 in combination with ibrutinib and radiation in patients with relapsed or refractory low-grade follicular lymphoma by assessing overall response rate. (Phase II)
I. To evaluate progression-free survival after treatment with intratumoral SD-101 in combination with ibrutinib and radiation in patients with relapsed or refractory low-grade follicular lymphoma. (Phase II)
OUTLINE: This is a phase Ib, dose-escalation study of TLR9 agonist SD-101 followed by a phase II study.
Patients undergo radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients receive TLR9 agonist SD-101 intratumorally (IT) on day 2 and on days 9, 16, 23, and 30. Patients also receive ibrutinib orally (PO) daily beginning on day 10 for 96 weeks in the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up every 3-6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intratumoral Injection of SD-101, an Immunostimulatory CpG, in Combination With Ibrutinib and Local Radiation in Relapsed or Refractory Low-Grade Follicular Lymphoma|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Treatment (radiation therapy, TLR9 agonist SD-101, ibrutinib)
Patients undergo radiation therapy on days 1 and 2. Within 12 hours of the completion of radiation therapy, patients receive TLR9 agonist SD-101 IT on day 2 and on days 9, 16, 23, and 30. Patients also receive ibrutinib PO daily beginning on day 10 for 96 weeks or in the absence of disease progression or unexpected toxicity.
Other: Laboratory Biomarker Analysis
Radiation: Radiation Therapy
Undergo radiation therapy
Drug: TLR9 Agonist SD-101
- Incidence of dose-limiting toxicity assessed using Common Terminology Criteria for Adverse Events version 4.0 (Phase Ib) [ Time Frame: Up to 60 months ]Dose-limiting toxicity will be assessed continuously throughout the trial. Adverse event information will be collected at each visit. Safety labs will be collected on week 2, 4, 6, 12 and every 12 weeks thereafter until the final study visit.
- Tumor response rates (Phase II) [ Time Frame: Up to 60 months ]Tumor response rates (complete response, partial response) will be calculated based on the Lugano classification for low-grade B-cell lymphomas.
- Progression-free survival (Phase II) [ Time Frame: Up to 60 months ]Progression will be defined using the Lugano Classification.
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): NCT02927964
|Contact: Destiny Phillipsfirstname.lastname@example.org|
|Contact: Hollis Mooreemail@example.com|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Destiny Phillips 650-498-1313 firstname.lastname@example.org|
|Contact: Hollis Moore 650-725-8589 email@example.com|
|Principal Investigator: Ronald Levy|
|Principal Investigator: Michael Khodaoust|
|Principal Investigator:||Ronald Levy||Stanford University|
|Principal Investigator:||Michael Khodadoust||Stanford University|