AML, Adult Clinical Trial
Official title:
Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as Conditioning Regimens for AML-MR
Verified date | June 2024 |
Source | Ruijin Hospital |
Contact | Xiaoxia Hu |
Phone | +862164370045 |
hxx12276[@]rjh.com.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | May 1, 2028 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 16-65 years and with an ECOG physical fitness score of 0-2 and an HCT-CI of less than 3; - Diagnosis: All enrolled cases were diagnosed with acute myeloid leukemia (AML-MR) after bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal examination, and gene mutation, and achieved hematological remission (bone marrow smear primitive cells <5%) and negative MRD before transplantation. - Have a medically qualified and suitable hematopoietic stem cell donor, including HLA-allogamous sibling donors, unrelated donors (HLA high-resolution 9-10/10 compatible) or related haploidentical donors; - No dysfunction of the heart, liver, lungs, kidneys, or other important organs, as defined as follows: ALT and AST =3 times the upper limit of normal; total bilirubin =2 times the upper limit of normal); BUN and Cr =1.25 times the upper limit of normal; electrocardiograms not suggestive of acute myocardial infarction or serious arrhythmias; cardiac echocardiography left ventricular ejection fraction =50%, no significant cardiac enlargement, valvular disease, or congenital heart disease; pulmonary function examination FEV1, FVC, DLCO = 60% of the predicted value. - The patient and his/her legal representative have the desire and requirement to undergo hematopoietic stem cell transplantation and sign an informed consent, willingness and compliance with the treatment plan, follow-up schedule, laboratory tests, etc. Exclusion Criteria: - AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions; - Active hepatitis B (HBV-DNA =1×10^3 copies/ml); - HIV-infected patients; - Active infections requiring intravenous antibiotic therapy; - There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc; - Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results; - Mentally challenged/unable to obtain informed consent; - Those judged by the investigator to be unsuitable for participation in this trial. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival | disease progression or death as a result of any causes | through study completion, an average of 2 year | |
Secondary | incidence of relapse rate | disease relapse | through study completion, an average of 2 year | |
Secondary | Non-recurrent mortality | death without disease progression or relapse | through study completion, an average of 2 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04623944 -
NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
|
Phase 1 | |
Not yet recruiting |
NCT06313437 -
Revumenib in Combination With 7+3 + Midostaurin in AML
|
Phase 1 | |
Terminated |
NCT04079738 -
Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
|
Phase 1/Phase 2 | |
Recruiting |
NCT06052813 -
A Study of BN104 in the Treatment of Acute Leukemia
|
Phase 1/Phase 2 | |
Recruiting |
NCT06027853 -
Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia
|
Phase 1 | |
Completed |
NCT02986620 -
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
|
||
Recruiting |
NCT05601466 -
Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
|
Phase 1 | |
Recruiting |
NCT06066905 -
A Study of Chidamide With AZA in MRD Positive AML After Transplant
|
N/A | |
Recruiting |
NCT05909501 -
Assessment of Geriatric Evaluations Impact on New AML Guidance
|
||
Terminated |
NCT04614636 -
FT538 in Subjects With Advanced Hematologic Malignancies
|
Phase 1 | |
Not yet recruiting |
NCT06420063 -
Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04128020 -
Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia
|
Phase 1 | |
Active, not recruiting |
NCT04749355 -
Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS
|
Phase 2 | |
Active, not recruiting |
NCT04755244 -
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
|
Phase 1/Phase 2 | |
Completed |
NCT03194685 -
Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
|
Phase 1/Phase 2 | |
Recruiting |
NCT03884829 -
A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
|
Phase 1 | |
Active, not recruiting |
NCT05177731 -
Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML
|
Phase 3 | |
Not yet recruiting |
NCT06377579 -
OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
|
||
Recruiting |
NCT05025098 -
Precision Therapy Versus Standard Therapy in AML and MDS in Elderly
|
Phase 2 | |
Not yet recruiting |
NCT06263387 -
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
|