- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325841
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
August 12, 2022 updated by: Beijing Boren Hospital
Phase II Study of Autologous Murine Anti-CD19 Chimeric Antigen Receptor T Cells Treating Refractory or Relapsed B Acute Lymphoblastic Leukemia Children
The investigators will conduct a phase II clinical trial of autologous murine anti-CD19 chimeric antigen receptor T cells treating refractory or relapsed B acute lymphoblastic leukemia children in Beijing Boren Hospital.
The study will be approved by the institutional review board of Beijing Boren Hospital, and informed consent will be obtained in accordance with the Declaration of Helsinki.
All these participants will be matched the diagnostic criteria for (r/r) B-ALL according to the WHO classification and complete morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis and leukemia fusion gene screening by multiplex nested reverse transcriptase-polymerase chain reaction (PCR).
Participants will be eligible if they are heavily treated B-ALL who failed from re-induction chemotherapy after relapse or continued MRD+ for more than three months, and had positive CD19 expression on leukemia blasts by FCM (>95% CD19).
After CAR T-cell infusion, clinical outcomes including overall survival (OS), Disease-free survival (DFS), adverse effects and relapse will be evaluated.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Pan, Master
- Phone Number: +8618911067969
- Email: panj@borenhospital.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Beijing Boren Hospital
-
Contact:
- Jing Pan, Master
- Phone Number: +8618911067969
- Email: panj@borenhospital.com
-
-
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.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who were diagnosed as primary refractory or relapsed B-ALL. All the patients matched the diagnostic criteria of ALL according to the WHO classification and conducted morphological evaluation, immunophenotype analysis by flow cytometry (FCM), cytogenetic analysis by routine G-banding karyotype analysis, screen of 56 leukemia-related fusion genes by multiplex nested reverse transcriptase-polymerase chain reaction (RT-PCR), and quantification of fusion genes by real-time PCR with ABL1 as reference. Extramedullary diseases (EMDs) were confirmed CD19+ by FCM and evaluated by positron emission tomography/computed tomography (PET/CT), CT, MRI or ultrasonography. The patient relapsed during chemotherapy or failed from re-induction chemotherapy (including first and second-generation TKIs) after relapse or had a persistent positive minimal residual disease (MRD) for three months. Patients had positive CD19 expression on leukemia blasts by FCM (>95% CD19 positive);
- Age from 0 to 18 years old;
- Children candidates can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form;
Exclusion Criteria:
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
- Serum creatinine and/or blood urea nitrogen over 1.5 times than normal range;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Obvious cranial lesions with cranial MRI;
- More than 20 counts/ul leukemic cells in cerebrospinal fluid;
- More than 30% leukemic cells in the blood;
- Stage III WHO/ECOG score;
- Organ recipients;
- Pregnant or breastfeeding;
- Active, uncontrolled infection, including hepatitis B, hepatitis C or human immunodeficiency virus (HIV);
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Autologous Murine Anti-CD19 CAR-T treatment
|
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses.
Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3.
No bridging chemotherapy was given between enrollment and infusion.
In CD19 T cell clinical trials, CAR-T cells was given once.
All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status.
Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR-T cell infusion to determine the disease status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR rate
Time Frame: 1 month
|
The complete remission(CR) rate to the CAR-T treatment
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (ACTUAL)
May 1, 2020
Primary Completion (ANTICIPATED)
May 1, 2024
Study Completion (ANTICIPATED)
November 1, 2024
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 26, 2020
First Posted (ACTUAL)
March 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 15, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BR-19-C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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