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NCT Number: NCT01263899

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

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).

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Indolent Lymphoma Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

SB1518

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Assess durability of response

    Time frame: 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.

  2. Assess number of patients with adverse events as a measure of safety and tolerability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

S*BIO

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2010
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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