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Chronic Lymphocytic Leukemia Treatment Study

Clinical Trial Title: 
A phase 3, randomized study to assess the efficacy and safety of ublituximab in combination with TGR-1202 compared to obinutuzumab in combination with chlorambucil in patients with chronic lymphocytic leukemia (CLL).
Clinical Trial Protocol ID: 
16010402
Clinical Trial Investigator Name: 
Parameswaran Venugopal, MD
Clinical Trial Protocol Description: 

This is a phase 3 study to test how effective the combination of two investigational drugs, ublituximab and TGR-1202, is in comparison to the combination of two FDA approved drugs, obinutuzumab and chlorambucil, as well as in comparison to ublituximab and TGR-1202 when used alone to treat patients with chronic lymphocytic leukemia.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have B-cell CLL that warrants treatment.
  • Have evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia.
  • Have massive, progressive, or symptomatic enlargement of the spleen; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis in the absence of infection; lymphocyte doubling time of less than 6 months.
  • Have autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy.
  • Have adequate organ system function.
  • Have a ECOG performance status less than or equal to 2.
  • Have the ability to swallow and retain oral medication.

You will be excluded from the study if any of the following criteria apply to you:

  • Are receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of randomization.
  • Have had autologous hematologic stem cell transplant within 3 months of study entry.
  • Have evidence of chronic active hepatitis B, chronic active hepatitis C infection, cytomegalovirus, or known history of HIV.
  • Have a known histological transformation from CLL to an aggressive lymphoma (Richter’s transformation).
  • Have prior exposure to idelalisib, duvelisib, ACP-319, or any drug that specifically inhibits phosphoinositide-3-kinase (PI3K).
  • Have received prior therapy with obinutuzumab and/or chlorambucil.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-2951
Contact Name: 
Roy Hard, RN, BSN