← Back to Search

CAR T-cell Therapy

CART19 for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Research Sponsored by Stephan Grupp MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial is testing a new cancer treatment called CART19 on patients with different types of leukemia. The goal is to see if it is effective, especially in patients who have not responded to other treatments.

Who is the study for?
This trial is for pediatric and young adult patients (0-29 years) with specific types of B-cell Acute Lymphoblastic Leukemia (B-ALL), including those with hypodiploid karyotype, t(17;19) translocation, high-risk KMT2A rearrangement, or CNS relapse without prior cranial radiation or bone marrow transplant. Participants must have CD19+ expression on leukemia cells and meet organ function criteria.Check my eligibility
What is being tested?
The study tests the effectiveness of Murine CART19 therapy in four different patient cohorts with various high-risk conditions of B-ALL. It's an open-label phase 2 trial where all participants receive the experimental treatment to see how well it works against their leukemia.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to T cell activation, such as fever and fatigue; possible damage to organs targeted by the engineered T cells; infusion-related reactions; and increased risk of infections due to altered immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia cells test positive for CD19.
Select...
I have B-cell Acute Lymphoblastic Leukemia that is CD19 positive.
Select...
I am between 0 and 29 years old.
Select...
My kidney function, based on my age and gender, meets the required levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
EFS Rate 1
EFS rate 2
MRD conversion
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Subjects with t(17;19) B-ALLExperimental Treatment1 Intervention
Group II: Subjects with hypodiploid B-ALLExperimental Treatment1 Intervention
Group III: Subjects with central nervous system (CNS) relapseExperimental Treatment1 Intervention
who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT)
Group IV: Infant subjects with very high risk KMT2A B-ALLExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Stephan Grupp MD PhDLead Sponsor
4 Previous Clinical Trials
232 Total Patients Enrolled
University of PennsylvaniaOTHER
1,994 Previous Clinical Trials
42,879,162 Total Patients Enrolled
Stephan Grupp, MD, PhDStudy DirectorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

Murine CART19 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04276870 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Subjects with hypodiploid B-ALL, Subjects with t(17;19) B-ALL, Infant subjects with very high risk KMT2A B-ALL, Subjects with central nervous system (CNS) relapse
Acute Lymphoblastic Leukemia Clinical Trial 2023: Murine CART19 Highlights & Side Effects. Trial Name: NCT04276870 — Phase 2
Murine CART19 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04276870 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the screening criteria for this trial?

"This particular study is enrolling 27 individuals with a history of bone cancer who are between 0 and 29 years old. It's important to note that candidates must meet the following additional requirements: 1.7 1.4, c.Cohort D: Subjects in a first or greater CNS relapse, prior to therapy with cranial XRT or HSCT for the current relapse, Age 0 to 29 years, ≥ 16 years , 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"

Answered by AI

Has the FDA issued a statement on Murine CART19?

"Murine CART19 clinical trial is in Phase 2, meaning that while there is some evidence to support the safety of this medication, its efficacy has yet to be proven."

Answered by AI

Has a trial like this been conducted before?

"Currently, there are 18 ongoing clinical trials for Murine CART19 in 115 cities and 22 countries. The first trial began in 2015 and was sponsored by Novartis Pharmaceuticals. That initial study had 97 patients and completed Phase 2 drug approval. In the 5 years since the first study, 11 more have been completed."

Answered by AI

How many individuals are signing up to participate in this research project?

"This trial is no longer looking for new participants. According to the clinicaltrials.gov listing, which was last updated on 1/11/2022, this study is now closed to enrolment. There are 1076 other trials currently underway that focus on bone marrow and 18 additional studies searching for patients with Murine CART19."

Answered by AI

Does this experiment have an age limit?

"According to the inclusion criteria, patients that meet the requirements for this trial must be between 0 and 29 years old. In addition, there are 175 studies for patients under 18 and 958 for senior citizens aged 65 or older."

Answered by AI

Are there any unfilled slots in this research project?

"This study is not open for recruitment at the moment. The trial was first posted on March 12th 2020 and updated January 11th 2022. For other studies, there are 1076 trials actively searching for patients with bone related issues and 18 Murine CART19 studies enrolling patients."

Answered by AI
~40 spots leftby Mar 2028