Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05026229
Study type Interventional
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Pengcheng He
Phone 0086-18991232609
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 7, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05024357 - A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL N/A
Completed NCT03545659 - Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Completed NCT03985826 - Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia
Withdrawn NCT03888534 - Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) Phase 1
Recruiting NCT03743246 - A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL) Phase 1/Phase 2
Active, not recruiting NCT01429610 - Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT03384654 - A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Phase 2
Completed NCT01317940 - Nutrition and Body Composition in Acute Lymphoblastic Leukemia Phase 2
Terminated NCT02454270 - A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies Phase 1
Completed NCT01331590 - Disrupting the Bone Marrow Microenvironment With G-CSF in Acute Lymphoblastic Leukemia Phase 0
Completed NCT04456959 - InO - A Retrospective Study of UK Patients With Leukaemia
Recruiting NCT03462095 - De-escalated Treatment Approach for Adult Ph-negative Acute Lymphoblastic Leukemia (ALL) N/A
Completed NCT01386619 - NK DLI in Patients After Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Phase 1/Phase 2
Withdrawn NCT03985215 - The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives
Recruiting NCT02328950 - A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome N/A
Withdrawn NCT02973191 - A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT02390752 - PLX3397 in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) Phase 1/Phase 2
Recruiting NCT02759822 - Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias N/A
Terminated NCT02428517 - Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015)
Terminated NCT01747499 - Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation Phase 1/Phase 2