Clinical Trial: Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

Brief Summary: The purpose of the study is to investigate whether combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in the treatment of Richter's Syndrome. The study will evaluate whether this regimen can reduce the amount of cancerous cells in your body. All of these agents are approved by the FDA Obinutuzumab is a protein molecule manufactured from a single cell population, has been approved by the Food and Drug Administration (FDA) for the treatment of CLL of SLL. Lenalidomide is for the treatment of patients with other blood cancers. Methylprednisolone is a type of steroid, and it is used in a wide variety of medical conditions. These agents and the combination of these agents are not approved for the treatment of Richter's Syndrome and are considered experimental.

Detailed Summary: This is a phase I trial to determine the safety and tolerability of the combination of obinutuzumab, lenalidomide, and HDMP for patients with RS. There is not a standard of care for patients with Richter's Syndrome (RS). Ten patients will be enrolled with RS diagnosed by histology or flow cytometry and CLL, regardless of prior treatment for either condition.
Sponsor: University of California, San Diego

Current Primary Outcome: Safety and tolerability of the combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in treatments with Richter's Syndrome (RS) measured Via Adverse Events [ Time Frame: 2 years ]

Measured Via Adverse Events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate of RS and CLL [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma.
  • Progression-free survival rate [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma. PFS is defined as the time from entry onto a study until lymphoma progression or death as a result of any cause.
  • Overall survival rate [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma. Defined as the time from entry onto the clinical trial until death as a result of any cause.
  • Patients able to receive a subsequent stem cell transplant (percentage) [ Time Frame: 12 months and 24 months ]
    Measure by percentage of patients able to receive subsequent tell cell transplant


Original Secondary Outcome: Same as current

Information By: University of California, San Diego

Dates:
Date Received: April 10, 2017
Date Started: August 2017
Date Completion: August 2020
Last Updated: April 12, 2017
Last Verified: April 2017