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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263899
• Other study ID #: SB1518-2010-005
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2010
• Last updated: April 19, 2012
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: S*BIO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT01263795

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Indolent Lymphoma
• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• SB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	MD Anderson Cancer Canter	Houston	Texas
United States	Weill Medical College of Cornell	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of Rochester James P. Wilmot Cancer Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
S*BIO

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes