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

NCT ID: NCT01263899

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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).

Conditions

Hodgkin Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SB1518

Group Type: EXPERIMENTAL

SB1518

Intervention Type: DRUG

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

Interventions

SB1518

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

Intervention Type: DRUG

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);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S*BIO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anas Younes, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center at University of Texas, Houston

Jonathan Friedberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester James P. Wilmot Cancer Center

Peter Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Julie Vose, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Richard Klasa, MD

Role: PRINCIPAL_INVESTIGATOR

British Columbia Cancer Center - Vancouver Centre

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Weill Medical College of Cornell

New York, New York, United States

University of Rochester James P. Wilmot Cancer Center

Rochester, New York, United States

MD Anderson Cancer Canter

Houston, Texas, United States

University of British Columbia

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

SB1518-2010-005

Identifier Type: -

Identifier Source: org_study_id

NCT01263795

Identifier Type: -

Identifier Source: nct_alias