Study Stopped
The therapeutic effect was not as expected
CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
AML
The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
1 other identifier
interventional
2
1 country
1
Brief Summary
Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, although it start late, several clinical trials have been register in ClinicalTrials.gov.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 13, 2021
September 1, 2021
2.8 years
March 15, 2018
September 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events that Are related to treatment
Determine the toxicity profile of the CD38/CD33/CD56/CD123/CD117/CD133/CD34/ Mucl-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
2 years
Secondary Outcomes (3)
Estimate 2 year overall survival(OS) after infusion of CD38/CD33/CD56/CD123/ CD117/CD133/CD34/Mucl-CART and sequential treatment
2 years
Estimate 2 year relapse rate after infusion of CD38/CD33/CD56/CD123/CD117/CD133/ CD34/Mucl-CART and sequential treatment
2 years
Estimate 2 year progression free survival after CD117/CD133/CD34/ Mucl-CART and sequential treatment
2 years
Study Arms (1)
CART therapy in Acute myeloid leukemia
EXPERIMENTALIn order to assess the safety and validity of using CAR-T therapy refractory/relapsed acute myeloid leukemia（AML）patients with one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART,subjects will receive 10\^6-10\^7/Kg transduced CAR T cells at one time.
Interventions
one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART therapy in Acute myeloid leukemia(AML)
Eligibility Criteria
You may qualify if:
- Relapsed/Refractory AML patients
- Positive for any of CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.(cytology, genetic testing)
- Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky Performance Status（KPS) score is more than 80.
- No cytapheresis and cell separation contraindication.
- Hemoglobin is more than 80 gram per litre.
- The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times the upper limit of normal;(4)Alanine transaminase（ALT）and glutamic-oxalacetic transaminase（AST）is less than 3 times the upper limit of normal,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
- After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
- Volunteered for this clinical trail and signed a consent form .
- Currently, chemotherapy and approved targeted therapies are ineffective for the patients.Or patients cannot tolerate current chemotherapy.
You may not qualify if:
- Active other disease and cannot control after treatment.
- Patients with actively infection of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
- Severe psychiatric disorder or other disease in central nervous system.
- Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
- Patients with infection of HIV .
- Pregnant or lactating women.
- Patients who have Graft-Versus-Host Disease (GVHD) should receive systemic administration of immunosuppressive agents.
- Patients have received other genetic therapy products.
- Patients who have received systemic administration of glucocorticoid agents in one week before CART therapy.
- Any situation may do harm to the subjects or interfere the results.
- Have had Prolonged QT interval or severe heart disease in the past.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Medical University Zhujiang Hospital
Guangdong, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanjie He
Zhujiang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 22, 2018
Study Start
April 1, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 13, 2021
Record last verified: 2021-09