BridgeMD
New treatment option for Acute Lymphoblastic Leukemia
Official title CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
ClinicalTrials.gov ID: NCT06847269
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
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
- CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell.
- 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 up to 21
You may be able to join if
- Autologous Apheresis and Manufacturing
- CD19+ leukemia\ \ with any of the following:
- Refractory disease (primary or in relapse)
- 2nd or greater relapse
- Any relapse after allogeneic hematopoietic cell transplantation
You likely can't join if
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen Treatment Inclusion Criteria:
- Age: ≤ 21 years of age
See the full eligibility criteria
- Autologous Apheresis and Manufacturing
- CD19+ leukemia\ \ with any of the following:
- Refractory disease (primary or in relapse)
- 2nd or greater relapse
- Any relapse after allogeneic hematopoietic cell transplantation
- 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT
- must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
- Age: ≤ 21 years of age
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
- Estimated life expectancy of \> 12 weeks. Patients with a history of prior allogeneic hematopoietic cell transplantation [HCT] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and...
- For females of child bearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen Treatment Inclusion Criteria:
- Age: ≤ 21 years of age
- Estimated life expectancy of \> 8 weeks
- Detectable disease
- Prior to planned CAR T cell infusion, patients with a history of prior allogeneic HCT must:
- be at least 3 months from HCT
- have no evidence of active GVHD
- have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion
- Adequate cardiac function defined as left ventricular ejection fraction \> 40%, or shortening fraction ≥ 25%
- EKG without evidence of clinically significant arrhythmia
- Adequate renal function defined as creatinine clearance or radioisotope GFR ³ 50 ml/min/1.73m2 (GFR ³ 40 ml/min/1.73m2 if \< 2 years of age)
- Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
- Total Bilirubin ≤ 3 times the upper limit of normal for age, except in people with Gilbert's syndrome
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
- Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
- For patients of child bearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- If sexually active, agreement to use birth control until 6 months after T cell infusion. Exclusion Criteria:
- Active CNS-3 disease
- Known primary immunodeficiency
- History of HIV infection
- Evidence of active, uncontrolled neurologic disease
- Severe, uncontrolled bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, 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, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, 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.