CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)
Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL)
2 other identifiers
interventional
30
1 country
1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied. The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedStudy Start
First participant enrolled
June 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedAugust 17, 2017
August 1, 2017
4.2 years
July 27, 2012
August 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of CD19-specific T-cells
Maximum tolerated dose (MTD) defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Dose limiting toxicity (DLT) defined as new adverse events of grade 3+ (CTCAE version 4) involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal parameters occurring with 6 weeks of infusion that are probably or definitely related to T-cell product. The maximum acceptable toxicity rate is 25%.
12 months
Secondary Outcomes (1)
Clinically Successful T-Cell Production
7 weeks
Study Arms (1)
T-Cell Infusion + Chemotherapy
EXPERIMENTALPeripheral blood mononuclear cells (PBMC) collected via venipuncture or steady state leukapheresis after enrollment. Clinically successful T-cell production defined as amount of T-cells required for dose level for which the patient is enrolled. Fludarabine 25 mg/m2 by vein on Days -5 to Day -3. Cyclophosphamide 250 mg/kg by vein on Days -5 to -3. Beginning dose of genetically modified cells is \> 5x10\^7/m2 but less than or equal to 5 x10\^8/m2 infused on Day 0.
Interventions
Blood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete.
25 mg/m2 by vein on Days -5 to Day -3.
250 mg/kg by vein on Days -5 to -3.
Beginning dose of genetically modified cells is \> 5x10\^7/m2 but less than or equal to 5 x10\^8/m2 infused on Day 0.
Eligibility Criteria
You may qualify if:
- Patients with a history of B-CLL, who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
- Confirmed history of CD19 positivity by flow cytometry.
- At least 8 weeks from last cytotoxic chemotherapy. Patients may continue ibrutinib or lenalidomide. These drugs will be discontinued 1 week prior to start of lymphodepleting chemotherapy.
- Karnofsky Performance Scale \> 60%.
- Absolute lymphocyte count \>100/uL.
- Adequate hepatic function, as defined by serum glutamate pyruvate (SGPT) \<3 x upper limit of normal; serum bilirubin and alkaline phosphatase \<2 x upper limit of normal, or considered not clinically significant by the study doctor or designee.
- Able to provide written informed consent.
- years of age.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study.
You may not qualify if:
- Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
- Presence of autoimmune phenomenon (AIHA, ITP) requiring steroid therapy.
- Presence of Grade 3 or greater toxicity from the previous treatment.
- Concomitant use of other investigational agents (ibrutinib or lenalidomide are allowed).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra M. Hosing, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2012
First Posted
July 31, 2012
Study Start
June 11, 2013
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
August 17, 2017
Record last verified: 2017-08