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

Phase 2

Completed

• Conditions: Hodgkin Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma
• Interventions: Drug: SB1518

• Registration Number: NCT01263899
• Lead Sponsor: S*BIO

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-21
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB1518	SB1518	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of Rochester James P. Wilmot Cancer Center; 🇺🇸 Rochester, New York, United States

Weill Medical College of Cornell; 🇺🇸 New York, New York, United States

MD Anderson Cancer Canter; 🇺🇸 Houston, Texas, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada