TLR9 Agonist SD-101 for Lymphoma, Mantle-Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University, School of Medicine, Palo Alto, CA
Lymphoma, Mantle-Cell+10 More
TLR9 Agonist SD-101 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of immunotherapy and chemotherapy may be more effective than chemotherapy alone for treating lymphoma.

See full description

Eligible Conditions

  • Lymphoma, Mantle-Cell
  • Marginal Zone Lymphoma (MZL)
  • Grade 3a Follicular Lymphoma
  • Mantle Cell Lymphoma (MCL)
  • Grade 2 Follicular Lymphoma
  • Refractory Follicular Lymphoma
  • Grade 1 Follicular Lymphoma
  • Recurrent Follicular Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether TLR9 Agonist SD-101 will improve 2 primary outcomes and 1 secondary outcome in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of Up to 60 months.

Up to 60 months
Incidence of dose-limiting toxicity assessed using Common Terminology Criteria for Adverse Events version 4.0 (Phase Ib)
Progression-free survival (Phase II)
Tumor response rates (Phase II)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

1 Treatment Group

Treatment (radiation therapy, TLR9 agonist SD-101, ibrutinib)
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. TLR9 Agonist SD-101 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 60 months for reporting.

Closest Location

Stanford University, School of Medicine - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, Mantle-Cell or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Biopsy confirmed Grade 1 or 2, or 3A follicular lymphoma; mantle cell lymphoma; or marginal zone lymphoma. Subjects must have relapsed from or are refractory to prior therapy.
Subjects must have at least one site of disease that is accessible for intratumoral injection of SD 101 (diameter ≥ 10mm), percutaneously.
Subjects must have at least one site of measurable disease (see Section 10.2.2 for definition of measurable disease) other than the injection site which is not included in the radiation field.
ECOG Performance Status of 0 or 1
Subjects must be 18 years of age or older.
Absolute neutrophil count (ANC) ≥ 1000/mm3 independent of growth factor support
Platelets: ≥ 100,000/mm3 or ≥ 50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
Hemoglobin: ≥ 8 g/dL (may be transfused)
Creatinine: Creatinine clearance > 25 mL/min
AST/ALT: ≤ 3 x ULN

Patient Q&A Section

What causes lymphoma, b-cell, marginal zone?

"It is suggested that both genetic and other causes of lymphoma result in a high rate of genetic errors in b-cells that are associated with a dysfunctional repair mechanism. The accumulation of these errors leads to a B-immunodeficiency condition, which may eventually contribute to lymphoma development." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, b-cell, marginal zone?

"The signs and symptoms of lymphoma, b-cell, marginal zone were as follows: persistent vomiting, swollen lymph nodes, enlargement of the spleen, fever, cough, hoarseness, fatigue, loss of appetite. The early signs of lymphoma are the same as those of myeloma." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, b-cell, marginal zone?

"The most common forms of lymphoma in the first instance are non-Hodgkin's lymphoma (NHL) and follicular lymphoma. However a wide range of lymphomas can occur in the B-cell, marginal zone of the lymphoid tissue (MLZ). This article aims to offer clinicians with a brief overview the diagnostic features, immunological behaviour, differential diagnosis as well as treatment options for NHL or MLZ." - Anonymous Online Contributor

Unverified Answer

Can lymphoma, b-cell, marginal zone be cured?

"When all known treatments such as chemotherapy, radiotherapy, autohemapheresis, immunotherapy and immunoanalogues are used, lymphoma, b-cell, marginal zone still behaves worse than other non-Hodgkin lymphoma groups." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma, b-cell, marginal zone a year in the United States?

"Approximately 80,000 people in the United States are diagnosed with lymphoma, b-cell, marginal zone a year. The vast majority of these cases are non-Hodgkin's lymphoma and may present with lymphadenopathy, skin lesions, or other extranodal lesions. These cases occur in all age groups, but are more common in older patients." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, b-cell, marginal zone?

"There are a variety of treatments commonly available for non-Hodgkin's lymphoma and marginal cell lymphoma. Lymphoblast therapy and peripheral stem cell transplantation are frequently utilized therapeutics for these patients, and are often effective and durable. The prognosis is generally good, although patients at a younger age, those with more serious disease, and women, have an increased survival rate." - Anonymous Online Contributor

Unverified Answer

What is ibrutinib?

"Ibrutinib is an effective new drug in relapsed/refractory marginal zone lymphomas with minimal to no systemic toxicity. A new drug, in combination with a chemotherapeutic regimen, can overcome the poor prognosis associated with marginal B-cell lymphoma and provides a new treatment option in the post-R-CHOP era." - Anonymous Online Contributor

Unverified Answer

How does ibrutinib work?

"Ibrutinib, in conjunction with cyclophosphamide and dexamethasone, effectively depletes and induces apoptosis of erythroblasts from erythrokeratosis verruciformis (EV) patients. Because ibrutinib has been associated with drug-induced polycythaemia (PCH), a direct effect on erythroid precursors must be considered plausible." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma, b-cell, marginal zone be?

"The prognosis of MALT lymphoma is excellent. The prognosis of MCL appears to be very poor unless patients are initially diagnosed as early as their first hospital visit with an accompanying diagnosis of CLL and a marrow evaluation is performed within six months. When MCL is evaluated at diagnosis and at presentation while still confined to marrow, it appears to have a survival rate with limited progression to and improved long-term outcomes compared to other BNCLLs evaluated in these two clinical settings." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ibrutinib?

"Ibrutinib is well tolerated. Commonly encountered adverse events include diarrhea, fatigue, constipation, nausea, peripheral edema, and rash. Patients should be informed of the potential risks with ibrutinib therapy such as skin or GI tract adverse events. Patient counseling on all of these side effects will assist the patient and the healthcare provider in deciding if ibrutinib therapy is effective and how to manage side effects." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ibrutinib for therapeutic use?

"Although data from Phase III randomized clinical trials are encouraging, the use of ibrutinib should be tailored to the individual patient and their disease, as well as to the context within which they will receive treatment." - Anonymous Online Contributor

Unverified Answer

Is ibrutinib typically used in combination with any other treatments?

"Ibrutinib was typically administered in combination with other therapies in the first-line setting to a large cohort of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma/B-cell non-Hodgkin lymphoma. Patients with high baseline levels of the lactate dehydrogenase activity were eligible to participate when appropriate. Clinical trials were registered with the Pharmaceutical Product Development Assistance Program of the Swiss Federal Drug Agency. ClinicalTrials.gov NCT01352276; NCT01357832." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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