Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
About 25% of adult patients with acute lymphoblastic leukemia (ALL) are associated with t (9; 22), positive philadelphia chromosome (Ph+ ALL), in whom BCR/ABL fusion gene can be detected in the bone marrow and peripheral blood. Although current treatment strategies using tyrosine kinase inhibitors (TKIs) such as dasatinib combined with chemotherapy have achieved high complete remission (CR) rates, the duration of remission is short, and most Ph+ ALL patients relapse within 2 years. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) bridging to CR remains the only strategy to cure Ph+ ALL. However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled. The participants will receive dasatinib combined with induction and consolidation chemotherapy to obtain molecular remission and then undergo allo-HSCT. After the above treatments, the patients will be randomly divided into two groups. The subjects in the group A will continue to use dasatinib for 1 year, while the patients in the group B receive dasatinib for 6 months post-HSCT. The measurable residual disease (MRD), CR, overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib for 1 year | Experimental | After the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year. |
|
| Dasatinib for 6 months | Experimental | After the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Take Dasatinib orally for 1 year or 6 months post-HSCT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients with Measurable Residual Disease (MRD) Positivity | MRD means the subclinical levels of residual leukemia. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Percentage of Patients with Complete Remission (CR) | CR means that the blood counts have returned to normal, the leukemia cannot be seen when a bone marrow sample is examined under the microscope, and the signs and symptoms of the ALL are gone. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS), months | The measure of time after allo-HSCT during which no sign of ALL is found. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Overall Survival (OS), months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengcheng He | Contact | 0086-18991232609 | hepc@163.com | |
| Xiaoyan Zheng | Contact | 0086-15829370502 | xiaoy_2008@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Pengcheng He | First Affiliated Hospital of Xian Jiaotong University | Study Chair |
| Xiaoning Wang | First Affiliated Hospital of Xian Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The length of time from the date of allo-HSCT that Ph+ ALL patients are still alive. |
| From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months. |
| Non-relapse Mortality (NRM), rate or percentage | NRM means death without recurrent or progressive disease after allo-HSCT. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Incidence of graft versus host disease (GVHD), rate or percentage | GVHD is a condition that might occur after allo-HSCT. In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. | From date of randomization until the date of GVHD occurrence or date of death from any cause, whichever came first, assessed up to 36 months. |
| Adverse Effects (AE) | An adverse effect is any untoward medical occurrence in clinical investigation subject administered dasatinib and which does not necessarily have a causal relationship with this treatment. | From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months. |
| Huachao Zhu |
| First Affiliated Hospital of Xian Jiaotong University |
| Principal Investigator |
| Juan Ren | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| Ying Chen | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| Ting Fan | First Affiliated Hospital of Xian Jiaotong University | Principal Investigator |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |