Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial
Official title:
A Randomized Controlled Study of Tyrosine Kinase Inhibitor Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed Philadelphia Chromesome Positive Adult Acute Lymphoblastic Leukemia
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 years old, newly diagnosed as Ph+ALL. - Sign the informed consent. - Have appropriate allo-HSCT donors. - Accept allo-HSCT. - Accept follow-up. Exclusion Criteria: - Liver and kidney function impairment: serum transaminase > 2 times of the upper limit of normal value, total bilirubin > 1.5 times of the upper limit of normal value, serum inosine > the upper limit of normal value (97 umol/L). - Active hepatitis B, hepatitis C or tuberculosis infection. - Can not tolerate the adverse effects of dasatinib. - Pregnancy. - Diagnosis of mental disorders. - Failed to reach molecular complete remission (MCR) after the early treatment. - Do not accept follow-up. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Secondary | 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. | |
Secondary | Overall Survival (OS), months | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05026229 -
A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in 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
|
||
Recruiting |
NCT05660473 -
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
|
Phase 2 | |
Withdrawn |
NCT03888534 -
Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy)
|
Phase 1 | |
Completed |
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 | |
Recruiting |
NCT05968963 -
Electronic Health Mindfulness-based Music Therapy Intervention for Patients Undergoing Allogeneic Stem Cell Transplantation
|
N/A | |
Active, not recruiting |
NCT01429610 -
Rituximab+mVPDL for CD20(+) Adult Acute Lymphoblastic Leukemia
|
Phase 2 | |
Completed |
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 |
NCT05873322 -
Glucose Intolerance and Diabetes Related to Treatment With Steroids and PEG- Asparaginase in Children and Adolescents With ALL and Lymphoma
|
||
Recruiting |
NCT02390752 -
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
|
Phase 1 |