- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02530515
Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia
Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (ex vivo autologous lymph node lymphocytes)
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
|
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Enrollment up to day 100 post T cell infusion for each arm.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Reconstitution
Time Frame: Up to 1 year
|
To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia
|
Up to 1 year
|
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.
|
Up to 1 year
|
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
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Body Weight
- Body Weight Changes
- Blood Platelet Disorders
- Leukocyte Disorders
- Leukemia, B-Cell
- Leukocytosis
- Infections
- Communicable Diseases
- Leukemia
- Weight Loss
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Thrombocytopenia
- Lymphadenopathy
- Leukemia, Prolymphocytic
- Lymphocytosis
Other Study ID Numbers
- 2014-0830 (OTHER: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2015-01546 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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