B-precursor Acute Lymphoblastic Leukemia
Conditions
Interventions
Single arm:FKC889/Tecartus (brexucabtagene autoleucel)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Relapsed or refractory B-precursor ALL defined as one of the following: (1) Primary refratory disease; (2) First relapse if first remission 5% blasts); 3. Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs; 4. Age 18 or older; 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1; 6. ANC >= 500/µL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy; 7. Platelet count >= 50,000/µL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy; 8. Absolute lymphocyte count >= 100/µL; 9. Adequate renal, hepatic, pulmonary and cardiac function defined as: (1) Creatinine clearance (as estimated by Cockcroft Gault) >= 60 cc/min; (2) Serum ALT/AST = 50%, no evidence of pericardial effusion as determined by an ECHO, no NYHA class III or class IV functional classification, and no clinically significant arrhythmias; (5) No clinically significant pleural effusion; (6) Baseline oxygen saturation > 92% on room air; 10. Females of childbearing potential must have a negative serum or urine pregnancy test; 11. In subjects previously treated with blinatumomab, CD19 tumor expression on blasts obtained from bone marrow or peripheral blood must be documented after completion of the most recent prior line of therapy. If CD19 expression is quantified, then blasts must be >= 90% CD19 positive.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Burkitt’s leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis; 2. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years; 3. History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study; 4. CNS abnormalities; (1) Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with >= 5 WBCs per mm3 with or without neurological changes; (2) Presence of CNS-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment; 12. Presence of any indwelling line or drain (eg, percuta
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall complete remission rate (CR + CRi) per independent review; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall complete remission rate (CR + CRi) per investigator assessment;Duration of Remission (DOR);Minimal Residual Disease (MRD) negative rate;Allogeneic stem cell transplant (Allogeneic SCT) rate;Overall survival (OS);Relapse-free Survival (RFS);Incidence of AEs and common terminology criteria for adverse events (CTCAE) grade changes in safety laboratory values;Incidence of anti-FKC889 antibodies;Changes over time in the EQ-5D score and VAS score; | — |
Countries
China
Contacts
Public ContactXiaojun Huang
Peking University People's Hospital
Outcome results
None listed