Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
Primary Purpose
Anemia, Cancer Fatigue, Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ex Vivo-activated Autologous Lymph Node Lymphocytes
Laboratory Biomarker Analysis
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (ex vivo autologous lymph node lymphocytes)
Arm Description
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Immune Reconstitution
To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia
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.
Incidence of Infections
To study the incidence of infections for up to 1 year following activated T cell infusion
Full Information
NCT ID
NCT02530515
First Posted
August 19, 2015
Last Updated
October 7, 2019
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02530515
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2015 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (ex vivo autologous lymph node lymphocytes)
Arm Type
Experimental
Arm Description
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
Intervention Type
Biological
Intervention Name(s)
Ex Vivo-activated Autologous Lymph Node Lymphocytes
Other Intervention Name(s)
X-ACT, X-ACT Autologous Lymph Node Lymphocytes
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
Description
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.
Time Frame
Enrollment up to day 100 post T cell infusion for each arm.
Secondary Outcome Measure Information:
Title
Immune Reconstitution
Description
To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia
Time Frame
Up to 1 year
Title
Overall Response Rates
Description
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.
Time Frame
Up to 1 year
Title
Incidence of Infections
Description
To study the incidence of infections for up to 1 year following activated T cell infusion
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chitra Hosing
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
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Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
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