Spots Global Cancer Trial Database for Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)
Official Title: Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies
Study ID: NCT01435720
Study Description
Brief Summary: The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.
Detailed Description: The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Mayo Clinic, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Fred Hutchinson Cancer Research Center/University of Washington Medical Center, Seattle, Washington, United States
West Virginia University Mary Babb Randolf Cancer Center, Morgantown, West Virginia, United States
Unversity of Cape Town - Groote Schuur Hospital, Cape Town, , South Africa
Pretoria East Hospital, Pretoria, , South Africa
Contact Details
Name: John A Lust, MD, PhD
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
