Clinical study of the safety and efficacy of CD19-CAR-T cells in patients with acute B-cell lymphoblastic leukemia

Conditions

Acute B-cell lymphoblastic leukemia

Zhang X, Yang J, Li J, Li W, Song D, Lu XA, Wu F, Li J, Chen D, Li X, Xu Z, Liu S, Li Z, Ying K, Lu P.

2021-08-0736 citations

Factors Predicting Long-Term Survival Following CD19 CAR T-Cell Therapy in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Xian Zhang, Junfang Yang, Wenqian Li, Gailing Zhang, Yunchao Su et al. (17 authors)

Blood2020-11-044 citations

10.1182/blood-2020-136897

Significant Long-Term Benefits of CAR T-Cell Therapy Followed By a Second Allo-HSCT for Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) Patients Who Relapsed after an Initial Transplant

Jianping Zhang, Junfang Yang, Xian Zhang, Jingjing Li, Xingyu Cao et al. (13 authors)

Blood2020-11-042 citations

10.1182/blood-2020-136014

Analysis of Factors Predicting Treatment Response of 254 Patients Who Received CD19-Targeted CAR-T Cell Therapy for Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Xian Zhang, Junfang Yang, Yanze Shi, Dan Song, Jingjing Li et al. (16 authors)

Blood2019-11-134 citations

10.1182/blood-2019-125503

Interventions

Case series:CD19-Chimeric Antigen Receptor T-Cell Immunotherapy

Eligibility

Sex/Gender

All

Age

3 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient; 2. Age 3-70 years old; 3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia; 4. B cells are positive for CD19 expression; 5. Peripheral blood tumor cell load 50 points; 7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

Exclusion criteria

Exclusion criteria: 1. Patients with non-B cell acute leukemia; 2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities 3. Active infection; 4. Human immunodeficiency virus (HIV) positive; 5. Acute and chronic graft-versus-host disease (GVHD)> Level 1 6. Pregnant or lactating women; 7. Patients do not agree to use effective contraception during the treatment period and following 3 months; 8. Patients who participated in other clinical studies at the same time; 9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study; 10. Long-term use greater doses of hormones than physiological doses.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate, ORR;	—

Secondary

Measure	Time frame
Relapse-Free Survival, RFS;Duration of Remission, DOR;Overall-Survival, OS;	—

Countries

China

Contacts

Public ContactPeihua Lu

Hebei Yanda Ludaopei Hospital

Peihua_lu@126.com+86 18611636171

Outcome results

None listed