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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 intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
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. The use of tyrosine kinase inhibitors (TKI) plus intensive chemotherapy has markedly improved the outcomes of Ph+ ALL. However, it's reported that 74% pf patients failed to complete the intended chemotherapy, and early death occured in a considerable proportion of patients during induction. The optimal balance between the intensity of chemotherapy and safety need to be explored. In this study, Ph+ ALL patients are enrolled. The participants will receive dasatinib and induction chemotherapy using VP regimen (vincristine and prednisone) to achieve complete remission (CR). Then the participants will be randomly divided into two groups. The subjects inthe group A will continue to use VP regimen plus dasatinib as consolidation, while the patients in the group B receive hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib, Vincristine and Prednisone | Experimental | After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone. |
|
| Dasatinib, Methotrexate and Cytarabine | Experimental | After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasatinib plus consolidation chemotherapy with vincristine and prednisone | Drug | After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Measurable Residual Disease (MRD) Positivity | MRD refers to 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 Participants 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 consolidation chemotherapy during which no sign of ALL is found. | From date of consolidation chemotherapy until disease progression, the end of follow-up or the date of death from any cause, whichever came first. |
| overall survival (OS), months |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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|
| dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine | Drug | After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine. |
|
|
The length of time from the date of diagnosis that Ph+ ALL patients are still alive. |
| From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first. |
| adverse effects (AE) | An adverse effect is any untoward medical occurrence in clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first. |
| 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 |
| 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 |
|---|---|
| D000069439 | Dasatinib |
| D060830 | Consolidation Chemotherapy |
| D014750 | Vincristine |
| D011241 | Prednisone |
| C047586 | VDA-P protocol |
| D008727 | Methotrexate |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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