T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adu… (NCT01860937) | Clinical Trial Compass
Active — Not RecruitingPhase 1
T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
United States23 participantsStarted 2013-05
Plain-language summary
The purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.
Who can participate
Age range
26 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 for Collection Arm of the protocol:
Age \< 26 years, whose disease meets one of the following 3 criteria:
* VHR\*
* Patients in 1st or subsequent marrow relapse (isolated or combined), at the time of relapse, during retrieval therapy, or after achievement of CR.
* Refractory disease \*Definitions of VHR B-ALL include the following:
* NCI HR-ALL and age ≥ 13 years at diagnosis
* CNS-3 leukemia at diagnosis
* Day 29/End of Induction BM MRD \> 0.01%
* Induction failure (M3 BM at Day 29/End of Induction)
* Hypodiploidy (n\< 44 chromosomes and/or a DNA index \< 0.81)
* t(9;22) ALL (Philadelphia Chromosome/Ph+ ALL)
* t(17;19) ALL or Ph-Like ALL
* MLL gene rearrangement
* IKZF1 deletions
* Intrachromosomal amplification of chromosome 21 (iAMP21) Please note patients that only meet the criteria for collection/storage of PBMCs will need to be reconsented prior to infusion of genetically modified T-cells.
Inclusion Criteria for Treatment Arm of this protocol:
* Patients must have a history of relapsed/refractory CD19+ B-ALL involving the marrow to be eligible for infusion of modified T cells.
* Please note ≥5% blasts by morphology, FISH/cytogenetics, molecular translocation and/or flow cytometry constitutes a bone marrow relapse on this protocol. Patients must also fulfill one of the following criteria to be eligible for infusion of modified T cells:
* Second or greater (≥2) relapse
* Early first marrow relapse (1st CR \<18 months)
* I…
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.
1Since this is a Phase 1 trial focused on measuring safety, what do we currently know — and not yet know — about the risks of using genetically modified T-cells that target CD19, and how does that uncertainty compare to other options available to us right now?
2This trial is no longer enrolling new patients — does that mean there are newer or more advanced versions of this CD19-targeted T-cell therapy that might be available to us, either in other trials or as approved treatments?
3Because my child or young adult has already relapsed, how does participating in an early-phase safety study weigh against pursuing standard salvage chemotherapy or other established approaches first?
4What does it actually mean day-to-day to be part of a study like this — how many hospital visits, how long would we need to stay nearby, and what happens if side effects require urgent care?
5Since the therapy involves genetically modifying the patient's own T-cells to attack CD19-positive cells, is there any concern about how this could affect normal B-cells long-term, and how would that be monitored and managed?
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.