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)
3 other identifiers
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2015
CompletedFirst Posted
Study publicly available on registry
August 21, 2015
CompletedStudy Start
First participant enrolled
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedResults Posted
Study results publicly available
October 29, 2019
CompletedOctober 29, 2019
October 1, 2019
2.4 years
August 19, 2015
July 31, 2019
October 7, 2019
Conditions
Outcome Measures
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.
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 Outcomes (3)
Immune Reconstitution
Up to 1 year
Overall Response Rates
Up to 1 year
Incidence of Infections
Up to 1 year
Study Arms (1)
Treatment (ex vivo autologous lymph node lymphocytes)
EXPERIMENTALPatients receive infusion of ex vivo-activated autologous lymph node lymphocytes IV over 10-30 minutes on day 0.
Interventions
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Chitra Hosing / Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra Hosing
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2015
First Posted
August 21, 2015
Study Start
December 18, 2015
Primary Completion
April 30, 2018
Study Completion
April 30, 2018
Last Updated
October 29, 2019
Results First Posted
October 29, 2019
Record last verified: 2019-10