A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Study Overview
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Brief Summary
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This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

Official Title
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A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Conditions
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Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma

Intervention / Treatment
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* Drug: SB1518


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically documented diagnosis of one of the following lymphoid malignancies: Hodgkin Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma); Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant; Able to understand and willing to sign the informed consent form. Exclusion Criteria: Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma; History of or active Central Nervous System (CNS) malignancy; Active graft-versus-host disease (GVHD);

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB1518<br> | Drug: SB1518<br>* SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy | Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma). | Every even numbered cycle from baseline to 30 days after the last dose of study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess durability of response | To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies. | Every even numbered cycle from baseline to 30 days after the last dose of study medication | 
| Assess number of patients with adverse events as a measure of safety and tolerability | To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies. | Every even numbered cycle from baseline to 30 days after the last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518