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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hodgkin Lymphoma, Mantle Cell Lymphoma, Indolent Lymphoma

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Trial Information

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


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);

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy

Outcome 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).

Outcome Time Frame:

Every even numbered cycle from baseline to 30 days after the last dose of study medication

Safety Issue:

No

Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center at University of Texas, Houston

Authority:

United States: Food and Drug Administration

Study ID:

SB1518-2010-005

NCT ID:

NCT01263899

Start Date:

December 2010

Completion Date:

February 2012

Related Keywords:

  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Indolent Lymphoma
  • Lymphoid malignancies
  • Hodgkin lymphoma
  • Mantle Cell Lymphoma
  • Indolent Lymphoma
  • SB1518
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
University of Rochester James P. Wilmot Cancer Center Rochester, New York  14642
Weill Medical College of Cornell New York, New York  10021
MD Anderson Cancer Canter Houston, Texas  77030