Clinical trial NCT01263899: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Mantle Cell Lymphoma
Indolent Lymphoma
Keywords: Lymphoid malignancies
Hodgkin lymphoma
Mantle Cell Lymphoma
Indolent Lymphoma
SB1518
Lead sponsor: S*BIO
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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);

Primary outcomes:
measure: Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy
timeFrame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Secondary outcomes:
measure: Assess durability of response
timeFrame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
measure: Assess number of patients with adverse events as a measure of safety and tolerability
timeFrame: Every even numbered cycle from baseline to 30 days after the last dose of study medication
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Weill Medical College of Cornell
state: New York
city: Rochester
country: United States
facility: University of Rochester James P. Wilmot Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Canter
state: Texas
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: MD Anderson Cancer Center at University of Texas, Houston
name: Anas Younes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester James P. Wilmot Cancer Center
name: Jonathan Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Peter Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Julie Vose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: British Columbia Cancer Center - Vancouver Centre
name: Richard Klasa, MD
role: PRINCIPAL_INVESTIGATOR
References: