Philadelphia, PANCT04276870Now EnrollingIRB Ready

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL Clinical Trial in Philadelphia, PA

Access cutting-edge pediatric and young adult patientswith hypodiploid or t(17;19) b-all treatment through this clinical trial at a research site in Philadelphia. Study-provided care at no cost to qualified participants.

Sponsored by Stephan Grupp MD PhD

Quick Self-Assessment

See if you qualify for this Philadelphia location

Preparing your pre-screening questions…

Expert Care in Philadelphia

Access pediatric and young adult patientswith hypodiploid or t(17;19) b-all specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pediatric and young adult patientswith hypodiploid or t(17;19) b-all treatment provided free

Apply for This Philadelphia Location

Check if you qualify for this pediatric and young adult patientswith hypodiploid or t(17;19) b-all clinical trial in Philadelphia, PA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Philadelphia

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Philadelphia site if eligible
  4. 4Begin participation

About This Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL Study in Philadelphia

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).

Sponsor: Stephan Grupp MD PhD

Who Can Participate

Inclusion 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: Subjects with confirmation of a hypodiploid karyotype (chromosome number fewer than 45) ii.Cohort B: Subjects with cytogenetic confirmation of the chromosomal translocation t(17;19) (Cohort B) b.Cohort C: Infants w/ newly diagnosed KMT2A rearranged B-ALL classified as very high risk by the following criteria: i.Age \< 3 months at diagnosis ii.Age \< 6 months and WBC \> 300,000x109/L at diagnosis or a poor prednisone response in induction iii.MRD positive \> 0.01 (or PCR \> 104) after 2 courses of standard infant ALL therapy. c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with cranial XRT or HSCT for the current relapse
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 1.5 1.4 ≥ 16 years 1.7 1.4
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 biopsy), the abnormalities are directly related to ALL infiltration of the liver. c.Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \< Grade 3 hypoxia; DLCO ≥ 40% (corrected for anemia) if PFTs are clinically appropriate as determined by the physician-investigator. d.Left Ventricular Shortening Fraction (LVSF) ≥ 28%, or Left Ventricular Ejection Fraction (LVEF) ≥ 45% by echocardiogram. In cases where quanitative assessment of LVSF/LVEF is not possible, a statement by the cardiologist that the ECHO shows qualititatively normal ventricular function wll suffice.
Adequate performance status defined as Lansky or Karnofsky score ≥ 50
Subjects of reproductive potential must agree to use acceptable birth control methods

Exclusion Criteria

For subjects 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. 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.
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT04276870) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL Treatment Options in Philadelphia, PA

If you're searching for pediatric and young adult patientswith hypodiploid or t(17;19) b-all treatment options in Philadelphia, PA, this clinical trial (NCT04276870) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pediatric and young adult patientswith hypodiploid or t(17;19) b-all specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pediatric and young adult patientswith hypodiploid or t(17;19) b-all clinical trials near you to find additional studies recruiting in your area.

More Leukemia Trials in Philadelphia, PA

See all leukemia clinical trials recruiting in Philadelphia — not just this study.

Browse Leukemia Trials in Philadelphia →

Browse More Trials by Condition

Leukemia TrialsB-Cell Acute Lymphoblastic Leukemia TrialsPulmonary Embolism TrialsAlzheimers Disease TrialsAtopic Dermatitis TrialsErectile Dysfunction TrialsInterstitial Cystitis TrialsOsteogenesis Imperfecta TrialsAll Conditions →

Ready to Join in Philadelphia?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Philadelphia, PA