This study is a multicenter, prospective, interventional clinical trial aimed at recruiting relapsed/refractory Ph-ALL patients at multiple stem cell transplantation centers, including the Stem Cell Transplantation Center of the Chinese Academy of Medical Sciences Hematology Hospital. The anticipated enrollment is 42 subjects. The enrolled patients are planned to receive a treatment regimen of chidamide in combination with venetoclax and obinutuzumab. Patients who achieve remission will undergo allogeneic stem cell transplantation, followed by continued oral maintenance therapy with chidamide for one year post-transplantation based on the disease condition.
Relapsed/refractory Ph-ALL patients who meet the inclusion criteria and provide informed consent will be enrolled in the study. They will receive combination chemotherapy with chidamide, venetoclax, and obinutuzumab. After one treatment cycle, if the patient achieves complete remission (CR) and minimal residual disease (MRD) negativity, they will proceed to the preparatory phase for allogeneic stem cell transplantation. In cases where MRD remains positive after one cycle of chemotherapy, the same regimen will be repeated for an additional cycle, followed by re-evaluation. Once MRD negativity is achieved, the patient will enter the preparatory phase for allogeneic stem cell transplantation. After successful hematopoietic recovery post-transplantation (neutrophil count \>0.5×10\^9/L, platelet count \>50×10\^9/L), chidamide 10mg qd will be added for maintenance therapy, which will be continued for one year post-transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
30mg twice weekly (BIW) for induction phase (cycle1-2,28 days per cycle)
400mg daily d1-14 induction phase (cycle1-2, 28 days per cycle)
0.6 mg/m2 on day 1 of cycle 1-2(28 days per cycle)
Overall survival
One-year overall survival rate (OS) after allogeneic stem cell transplantation.
Time frame: 24months
Complete remission
Complete remission (CR) rate following treatment with obinutuzumab in combination with chidamide and venetoclax.
Time frame: 24months
relapse-free survival
One-year relapse-free survival (RFS) after allogeneic stem cell transplantation.
Time frame: 24months
Incidence of graft-versus-host disease
Incidence of graft-versus-host disease (GVHD) following allogeneic stem cell transplantation.
Time frame: 24months
Engraftment rate
Engraftment rate post-transplantation.
Time frame: 24months
Minimal residual disease rate
Minimal residual disease (MRD) clearance rate following chemotherapy.
Time frame: 24months
Bridging transplant rate.
Bridging transplant rate.
Time frame: 24months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.