Clinical trial NCT02530515: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-21
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
timeFrame: Enrollment up to day 100 post T cell infusion for each arm.
Secondary outcomes:
measure: Immune Reconstitution
timeFrame: Up to 1 year
measure: Overall Response Rates
timeFrame: Up to 1 year
measure: Incidence of Infections
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Chitra Hosing
role: PRINCIPAL_INVESTIGATOR
References: