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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530515
• Other study ID #: 2014-0830
• Secondary ID: NCI-2015-0154620
• Status: Completed
• Phase: Phase 2
• Start date: December 18, 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: October 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Cancer Fatigue
• Chronic Lymphocytic Leukemia
• Communicable Diseases
• Fever
• Infection
• Infectious Disorder
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic
• Lymphadenopathy
• Lymphocytosis
• Night Sweats
• Prolymphocytic Leukemia
• Recurrent Chronic Lymphocytic Leukemia
• Richter Syndrome
• Secondary Malignant Neoplasm
• Thrombocytopenia
• Weight Loss

Intervention

Biological:
• Ex Vivo-activated Autologous Lymph Node Lymphocytes
Given IV

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.	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.	Enrollment up to day 100 post T cell infusion for each arm.
Secondary	Immune Reconstitution	To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia	Up to 1 year
Secondary	Overall Response Rates	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.	Up to 1 year
Secondary	Incidence of Infections	To study the incidence of infections for up to 1 year following activated T cell infusion	Up to 1 year

External Links

•   MD Anderson Cancer Center Website