Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood (NCT01497184) | Clinical Trial Compass
CompletedPhase 1
Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
United States95 participantsStarted 2011-12
Plain-language summary
The goal of this clinical research study is to learn if researchers can successfully and safely give HSCT patients an infusion of white blood cells (called T-cells) that have been genetically changed. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene transfer." Researchers want to learn if these genetically-changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia, after they have received standard allogeneic HSCT. Researchers want to find out the highest dose of these special T-cells that can be given safely to leukemia and lymphoma patients. Researchers also want to learn how long the changed T-cells stay in your body, and if adding them to standard transplant can improve how you respond to treatment.
Who can participate
Age range
1 Year – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with a history of CD19+ lymphoid malignancies that are primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time:1) Acute Lymphoblastic Leukemia (ALL) with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure,and/or evidence of minimal residual disease, 2) acute biphenotypic leukemia, or 3) double hit nonHodgkin's lymphoma. Non-Hodgkin's Lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). Double hit lymphomas in first remission or more advanced disease. Small Lymphocytic Lymphoma (SLL), or Chronic Lymphocytic Leukemia (CLL) with progressive disease following standard therapy.
. Age 1 to 65 years old.
. Lansky performance score \>/= 60% for patients \</= 16 years of age, or Zubrod performance 0-1 or Karnofsky greater than or equal to 80% for patients \> 16 years of age.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated dose (MTD) of Donor Lymphocyte Infusion (DLI)
. Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
. 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.
. Patient is planning to receive or has received an HLA-identical matched family, related haploidentical donor (\</= 7/8 allele match), or at least 8/8 matched unrelated allogeneic HSCT.
Exclusion criteria
. Patients with known allergy to bovine or murine products.
. Active grade 2-4 acute GVHD at time of DLI.
. Systemic corticosteroid use within 72 hours of DLI unless required for physiologic replacement.
. Less than 80% donor chimerism from peripheral blood within 30 days of DLI administration, if T cells are made from allogeneic donor.
. Experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to DLI.
. Currently using an investigational agent at time of DLI.
. Active infection defined as positive culture, if available, for bacteria, fungus, or virus within a 3-day period prior to DLI and/or fever greater than 38°C within 24 hours prior to DLI.
. Positive beta HCG in female of child-bearing potential defined as not post menopausal for 12 months or absence of previous surgical sterilization.