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New treatment option for Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL
Official title Orphan Indications for CD19 Redirected Autologous T Cells
ClinicalTrials.gov ID: NCT04276870
What this study is testing
What is Murine CART19?
Murine CART19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pediatric and young adult patientswith hypodiploid or t(17;19) b-all.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 29
You may be able to join if
- Signed informed consent form must be obtained prior to any study procedure.
- Male and female patients with documented CD19+ B-ALL a.Cohort A \& B: Patients, regardless their response to initial or relapsed B ALL therapy, with...
- Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue.
- Age 0 to 29 years
- Adequate organ function defined as:
You likely can't join if
- For people with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion.
- Active hepatitis B or active hepatitis C.
- HIV Infection.
- Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
- Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is...
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
See the full eligibility criteria
- Signed informed consent form must be obtained prior to any study procedure.
- Male and female patients with documented CD19+ B-ALL a.Cohort A \& B: Patients, regardless their response to initial or relapsed B ALL therapy, with the following characteristics: i.Cohort A: people with confirmation of...
- Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue.
- Age 0 to 29 years
- Adequate organ function defined as:
- A serum creatinine based on age/gender as follows: Maximum Serum Creatinine (mg/dL) Age Male Female 0 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1.0 1.0 10 to \< 13 years 1.2 1.2 13 to \< 16 years...
- Adequate liver function: i.ALT≤ 5 x ULN; ALT ii.Total bilirubin ≤ 3 x ULN iii.ALT and/or bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver...
- Adequate performance status defined as Lansky or Karnofsky score ≥ 50
- people of reproductive potential must agree to use acceptable birth control methods
- For people with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion.
- Active hepatitis B or active hepatitis C.
- HIV Infection.
- Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
- Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion...
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
- Pregnant or nursing (lactating) women.
- Uncontrolled active infection.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.