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Completed

NCT Number: NCT02530515

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

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.

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Key information

Conditions

Anemia Blood Platelet Disorders Body Temperature Changes Body Weight Body Weight Changes Cancer Fatigue Chronic Disease Chronic Lymphocytic Leukemia Communicable Diseases Cytopenia Disease Attributes Fever Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Infectious Disorder Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Leukocyte Disorders Leukocytosis Lymphadenopathy Lymphatic Diseases Lymphocytosis Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Second Primary Night Sweats Pathologic Processes Pathological Conditions, Signs and Symptoms Prolymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Richter Syndrome Secondary Malignant Neoplasm Signs and Symptoms Thrombocytopenia Weight Loss

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ex Vivo-activated Autologous Lymph Node Lymphocytes

Biological

Given IV

Other names: X-ACT, X-ACT Autologous Lymph Node Lymphocytes

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

    Time frame: Enrollment up to day 100 post T cell infusion for each arm.

    Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in >50% of patients enrolled.

Secondary outcomes

  1. Immune Reconstitution

    Time frame: Up to 1 year

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

  2. Overall Response Rates

    Time frame: Up to 1 year

    The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.

  3. Incidence of Infections

    Time frame: Up to 1 year

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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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