RECRUITING

Orphan Indications for CD19 Redirected Autologous T Cells

Conditions

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL Infants With Very High Risk KMT2A B-ALL Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

CD19-Directed Chimeric Antigen Receptor CD19 Redirected Autologous T Cells (CART19) for Orphan Indications of Pediatric B Cell Acute Lymphoblastic Leukemia (B ALL)

Quick Facts

Study Start:2020-03-12

Study Completion:2037-03-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04276870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 29 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent form must be obtained prior to any study procedure. 2. Male and female patients with documented CD19+ B-ALL 3. Expression of CD19 on leukemic blasts demonstrated by flow cytometry of bone marrow, cerebrospinal fluid, or peripheral blood 4. Age 0 to 29 years 5. Adequate organ function defined as: 1. A serum creatinine based on age/gender as follows: 2. Adequate liver function: 6. Adequate performance status defined as Lansky or Karnofsky score ≥ 50 7. Subjects of reproductive potential must agree to use acceptable birth control methods	1. For subjects with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion. 2. Active hepatitis B or active hepatitis C. 3. HIV Infection. 4. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy. 5. 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. 6. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity. 7. Pregnant or nursing (lactating) women. 8. Uncontrolled active infection.

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent form must be obtained prior to any study procedure.
2. Male and female patients with documented CD19+ B-ALL
3. Expression of CD19 on leukemic blasts demonstrated by flow cytometry of bone marrow, cerebrospinal fluid, or peripheral blood
4. Age 0 to 29 years
5. Adequate organ function defined as:
1. A serum creatinine based on age/gender as follows:
2. Adequate liver function:
6. Adequate performance status defined as Lansky or Karnofsky score ≥ 50
7. Subjects of reproductive potential must agree to use acceptable birth control methods

1. For subjects with a CNS relapse, prior cranial XRT or BMT for the current relapse is an exclusion.
2. Active hepatitis B or active hepatitis C.
3. HIV Infection.
4. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
5. 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.
6. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
7. Pregnant or nursing (lactating) women.
8. Uncontrolled active infection.

Contacts and Locations

Study Contact

Amanda DiNofia, MD, PhD

CONTACT

215-590-5476

DiNofiaA@chop.edu

Raabia Khan, MPH

CONTACT

267-426-4947

khanr@chop.edu

Principal Investigator

Stephan Grupp, MD, PhD

STUDY_DIRECTOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Stephan Grupp MD PhD

Stephan Grupp, MD, PhD, STUDY_DIRECTOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-12

Study Completion Date2037-03-10

Study Record Updates

Study Start Date2020-03-12

Study Completion Date2037-03-10

Terms related to this study

Additional Relevant MeSH Terms

Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL
Infants With Very High Risk KMT2A B-ALL
Patients With Central Nervous System Relapse Who Did Not Receive Cranial Radiation or Bone Marrow Transplantation