A Phase II Study of CAL-101 plus Rituximab in Elderly Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Protocol
10-224
Full Title
A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of Idelalisib Alone and in Combination with Rituximab in Elderly Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Phase
II
Purpose

Rituximab is one of the drugs used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) — cancers which typically affect elderly patients. Despite this treatment, however, some patients experience disease recurrence. Doctors are therefore seeking more effective therapies for these diseases.

In this study, investigators want to assess the effectiveness of adding the investigational drug CAL-101 to treatment with rituximab in elderly patients with CLL or SLL that has not yet been treated. CAL-101 works by inhibiting an enzyme called PI3 kinase, which fuels the growth of these cancers. The drug is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of CLL or SLL.
  • Patients may not have received prior therapy for their cancer, though steroids may have been taken to relieve symptoms.
  • Patients must be age 65 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Andrew Zelenetz at 212-639-2656.

Disease(s)
Leukemia
Leukemia: Chronic Lymphocytic Leukemia
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations