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

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Brief Title

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

Official Title

Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)

Brief Summary

      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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex
      vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic
      leukemia.

      SECONDARY OBJECTIVES:

      I. To study immune reconstitution following infusion of activated T-cells in patients with
      chronic lymphocytic leukemia.

      II. To study the incidence of infections for up to 1 year following activated T cell
      infusion.

      III. To study the overall response rates.

      OUTLINE:

      Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes
      intravenously (IV) over 10-30 minutes on day 0.

      Patients who have been previously treated on study, and subsequently need additional
      infusions, may be retreated with previously cryopreserved expanded cells at the same or lower
      dose level 6-12 months after the first infusion.

      After completion of study treatment, patients are followed up at 1.5 years and then every 6
      months for up to 5 years.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.

Secondary Outcome

 Immune Reconstitution

Condition

Anemia

Intervention

Ex Vivo-activated Autologous Lymph Node Lymphocytes

Study Arms / Comparison Groups

 Treatment (ex vivo autologous lymph node lymphocytes)
Description:  Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

8

Start Date

December 18, 2015

Completion Date

April 30, 2018

Primary Completion Date

April 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Chitra Hosing, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02530515

Organization ID

2014-0830

Secondary IDs

NCI-2015-01546

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Chitra Hosing, Principal Investigator, M.D. Anderson Cancer Center

Verification Date

October 2019