Back to resultsA Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Primary Purpose
Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB1518
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518
Eligibility Criteria
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);
Sites / Locations
- University of Nebraska Medical Center
- Weill Medical College of Cornell
- University of Rochester James P. Wilmot Cancer Center
- MD Anderson Cancer Canter
- University of British Columbia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SB1518
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Assess durability of response
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
To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01263899
Brief Title
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Official Title
A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S*BIO
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma
Keywords
Lymphoid malignancies, Hodgkin lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma, SB1518
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SB1518
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SB1518
Intervention Description
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
Primary Outcome Measure Information:
Title
Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy
Description
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).
Time Frame
Every even numbered cycle from baseline to 30 days after the last dose of study medication
Secondary Outcome Measure Information:
Title
Assess durability of response
Description
To assess the durability of response following SB1518 treatment in patients with advanced lymphoid malignancies.
Time Frame
Every even numbered cycle from baseline to 30 days after the last dose of study medication
Title
Assess number of patients with adverse events as a measure of safety and tolerability
Description
To assess the safety and tolerability of SB1518 administered orally once daily in patients with advanced lymphoid malignancies.
Time Frame
Every even numbered cycle from baseline to 30 days after the last dose of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
MD Anderson Cancer Center at University of Texas, Houston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Friedberg, MD
Organizational Affiliation
University of Rochester James P. Wilmot Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Martin, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Klasa, MD
Organizational Affiliation
British Columbia Cancer Center - Vancouver Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Weill Medical College of Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
MD Anderson Cancer Canter
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
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