Hodgkin Lymphoma, Indolent Lymphoma, Mantle Cell Lymphoma
Conditions
Keywords
Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518
Brief summary
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).
Interventions
DRUGSB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
Sponsors
S*BIO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy | Every even numbered cycle from baseline to 30 days after the last dose of study medication | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess durability of response | Every even numbered cycle from baseline to 30 days after the last dose of study medication | To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies. |
| Assess number of patients with adverse events as a measure of safety and tolerability | Every even numbered cycle from baseline to 30 days after the last dose of study medication | To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies. |
Countries
Canada, United States
Outcome results
None listed