ALL, Adult Clinical Trial
Official title:
Newly Diagnosed Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). Sequential Treatment With Ponatinib and the Bispecific Monoclonal Antibody Blinatumomab vs Chemotherapy and Imatinib
This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients based on the combination of Ponatinib with Blinatumomab. The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients (>65 years old). Patients will be randomized 2:1 to receive the experimental or control arm. If patients in the control arm do not achieve a CHR and/or MRD negativity, after the sixth consolidation cycle (week 20), a crossover to receive Blinatumomab is planned. Likewise, if patients in the control arm develop an ABL1 mutation at any time of treatment, they will switch to experimental arm. HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years. After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm, patients aged 18-65 will be stratified for transplant allocation.
This is a randomised, open-label, multicenter, phase III study for adult de novo Ph+ ALL patients (≥18 years, no upper age-limit) based on the combination of the pan-TKI Ponatinib, with the bispecific monoclonal antibody Blinatumomab. The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients (>65 years old). Patients (≥18 years, no upper age limit) will be randomized 2:1 to receive the experimental or control arm. If patients in the control arm do not achieve a CHR and/or MRD negativity, after the sixth consolidation cycle (week 20), a crossover to receive Blinatumomab is planned. Likewise, if patients in the control arm develop an ABL1 mutation at any time of treatment, they will switch to experimental arm. HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years. After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm, patients aged 18-65 will be stratified for transplant allocation. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05024357 -
A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL
|
N/A | |
Recruiting |
NCT05026229 -
A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in 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 | |
Recruiting |
NCT06250959 -
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
|
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
|