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 : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Grade 1 Follicular Lymphoma Grade 2 Follicular Lymphoma Grade 3a Follicular Lymphoma Recurrent Follicular Lymphoma Refractory Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma||Drug: Ibrutinib Radiation: Radiation Therapy Drug: TLR9 Agonist SD-101||Phase 1 Phase 2|
Phase 1b: - To determine the recommended phase 2 dose (RP2D) of intratumoral SD 101 in combination with ibrutinib and radiation in subjects with relapsed or refractory B cell lymphoma . - To determine the safety and tolerability of SD 101 in combination with ibrutinib and radiation in subjects with relapsed or refractory B cell lymphoma
Phase 2: -To evaluate the efficacy of intratumoral SD 101 in combination with ibrutinib and radiation in subjects with relapsed or refractory B cell lymphoma by assessing overall response rate
Phase 2: - To evaluate progression free survival after treatment with intratumoral SD 101 in combination with ibrutinib and radiation in subjects with relapsed or refractory B cell lymphoma
- To evaluate the induction of tumor-specific immune responses by treatment with intratumoral SD-101 in combination with ibrutinib and radiation in patients with relapsed or refractory B cell lymphoma
|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, 30 and 37. Patients also receive ibrutinib PO daily beginning on day 9 for 96 weeks or in the absence of disease progression or unexpected toxicity.
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 rate of intratumoral SD 101 in combination with ibrutinib and radiation in subjects will be assessed. 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 free Survival is defined as the time elapsed between treatment initiation (Day 1) and tumor progression or death from any cause. Progression will be defined using the Lugano Classification. This outcome will be measured on any individual who has received at least one intratumoral injection of SD 101 at the recommended phase 2 dose level.
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: Rachel Greensteinfirstname.lastname@example.org|
|United States, California|
|Stanford University, School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Rachel Greenstein 650-723-2312 email@example.com|
|Principal Investigator: Ronald Levy|
|Principal Investigator: Michael Khodaoust|
|Principal Investigator:||Ronald Levy||Stanford University|
|Principal Investigator:||Michael Khodadoust||Stanford University|