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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination drug group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chidamide | Drug | 30mg twice weekly (BIW) for induction phase (cycle1-2,28 days per cycle) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | One-year overall survival rate (OS) after allogeneic stem cell transplantation. | 24months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission | Complete remission (CR) rate following treatment with obinutuzumab in combination with chidamide and venetoclax. | 24months |
| relapse-free survival | One-year relapse-free survival (RFS) after allogeneic stem cell transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Venetoclax Oral Tablet | Drug | 400mg daily d1-14 induction phase (cycle1-2, 28 days per cycle) |
|
| Inotuzumab Ozogamicin | Drug | 0.6 mg/m2 on day 1 of cycle 1-2(28 days per cycle) |
|
| 24months |
| Incidence of graft-versus-host disease | Incidence of graft-versus-host disease (GVHD) following allogeneic stem cell transplantation. | 24months |
| Engraftment rate | Engraftment rate post-transplantation. | 24months |
| Minimal residual disease rate | Minimal residual disease (MRD) clearance rate following chemotherapy. | 24months |
| Bridging transplant rate. | Bridging transplant rate. | 24months |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C579720 | venetoclax |
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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