ALL, Adult Clinical Trial
Official title:
Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects. In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated. The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04722848 -
Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph+ ALL
|
Phase 3 | |
| Recruiting |
NCT05026229 -
A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL
|
N/A | |
| Recruiting |
NCT05024357 -
A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL
|
N/A | |
| Recruiting |
NCT06052813 -
A Study of BN104 in the Treatment of Acute Leukemia
|
Phase 1/Phase 2 | |
| Completed |
NCT05928104 -
Optimising Pharmacist-led Medication Reviews in Primary Care
|
||
| Recruiting |
NCT05473910 -
A Study of TSC-100 and TSC-101 in AML, ALL and MDS Patients Undergoing Haploidentical Donor Transplantation
|
Phase 1 | |
| Recruiting |
NCT03884829 -
A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
|
Phase 1 | |
| Active, not recruiting |
NCT03541083 -
Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.
|
Phase 2 | |
| Active, not recruiting |
NCT03751709 -
Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL
|
Phase 1 | |
| Recruiting |
NCT04482894 -
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS
|
Phase 2 | |
| Recruiting |
NCT05480904 -
Characterizing Sleep Among Long-term Survivors of Childhood Cancer
|
||
| Completed |
NCT04357041 -
COVID-19 Survey Study on Dietary Intake, Physical Activity and Overall Well-being
|