Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
With
Children's Hospital of Philadelphia
Age
0–29
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Signed informed consent form must be obtained.
2. Relapsed or refractory B-cell ALL:
a. Cohort A: Patients with newly diagnosed VHR B-ALL or high-risk relapse of B-ALL who meet one of the following criteria:
i. Newly diagnosed NCI HR B-ALL with induction failure: M3 marrow (\>25% blasts) at end of induction OR
ii. First marrow relapse of B-ALL at \< 36 months from diagnosis OR iii. 2nd or greater relapse OR
iv. Any relapse after allogeneic HSCT and ≥ 4 months from SCT at enrollment OR
v. Refractory disease defined as having not achieved an MRD-negative and/or CSF-negative CR after ≥ 2 chemotherapy regimens/cycles of frontline therapy or 1 cycle of reinduction therapy for patients in first relapse OR
vi. Ineligible for allogeneic SCT because of:
1. Comorbid disease
2. Other contraindications to allogeneic SCT conditioning regimen
3. Lack of suitable donor
4. Prior SCT
3\. Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue by flow cytometry at relapse (or a recent sample in the case of refractory disease). If the patient has received CD19-directed therapy, then the flow cytometry should be obtained after this therapy to show CD19 expression.
4\. Adequate organ function defined as:
1. A serum creatinine based on age/gender
2. ALT≤ 500 U/L
3. Bilirubin ≤2.0 mg/dl
4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea, \< Grade 3 hypoxia; DLCO ≥ 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the treating investigator
5. Left Ventricular Shortening Fraction (LVSF) ≥ 28% or Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO, or adequate ventricular function documented by a scan or a cardiologist.
5\. Age 3 months to 29 years. 6. Adequate performance status (Lansky or Karnofsky score ≥50). 7. Subjects of reproductive potential must agree to use acceptable birth control methods.
You may not be if
1. Active hepatitis B or active hepatitis C.
2. HIV Infection.
3. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
4. Concurrent use of systemic steroids or immunosuppression 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 or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
5. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
6. Pregnant or nursing (lactating) women.
7. Uncontrolled active infection.
8. Active medical disorder that, in the opinion of the investigator, would substantially increase the risk of uncontrollable CRS or neurotoxicity.
Clareo Health | Study of huCART19 for Very High-Risk (VHR) Subsets of Pediatric B-ALL
