Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Anemia, Cancer Fatigue, Chronic Lymphocytic Leukemia, Fever, Infectious Disorder, Lymphadenopathy, Lymphocytosis, Night Sweats, Prolymphocytic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Richter Syndrome, Secondary Malignant Neoplasm, Thrombocytopenia, Weight Loss

In brief

This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Key facts

Study ID

NCT02530515

Run by

M.D. Anderson Cancer Center

People needed

8

Starts

2015-12-18

Expected to finish

2018-04-30

Last updated by the study team

2019-10-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
• Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:
• Weight loss of more than 10% over the preceding 6 months; or
• Extreme fatigue attributable to progressive disease; or
• Fever or night sweats without evidence of infection; or
• Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or
• Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time < 6 months); or
• Prolymphocytic or Richter's transformation; or
• Patients with CLL who have received at least one prior line of therapy; or
• Patients with CLL who have frequent infections and/or recurrent secondary cancers
• No active central nervous system (CNS) disease
• All patients must have a Karnofsky performance score > 60%
• Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
• Patients must not have untreated or uncontrolled life-threatening infection
• Patients must sign informed consent

You may not qualify if…

• Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 weeks of registration
• Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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