Acute Myeloid Leukemia Clinical Trial
— IMCG-EAMLOfficial title:
Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation (MST-group)or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines. - Patients have not been treated before. - Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2. - Patients must have a HLA mismatched donor who should be able to provide informed consent. - All genders and races are eligible. - ALT and AST=3 ×ULN, TBIL=1.5 × ULN, Cr=2 ×ULN or CrCl=40 mL/min - By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range. - Donors must be able to safely undergo leukapheresis. Exclusion Criteria: - received operation 4 weeks before randomization - acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase; - active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol - occurred stroke or intracranial hemorrhage within 6 months before randomization. - Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant. - There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA). - Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection - Any situation processed by the PI that will be damaged to the patients safety. - Patients and / or authorized family member refuse to sign the consent. - attend other clinical researchers in 3 months. - Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Academy of Military Medical Sciences , | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | treatment-related mortality | Early mortality: death within 4 weeks after initiation of induction therapy | 2 years | Yes |
Other | donor chimerism or microchimerism | at count recovery prior to each new cycle of therapy, at 4 weeks after the last round of consolidation, and if still positive, every 3 months after completing therapy for up to 2 years | No | |
Other | donor versus leukemia effect | Analysis of donor WT1 positive CD8 T cells by flow cytometry | 2 years | No |
Other | recipient versus leukemia effect | Analysis of recipient WT1 positive CD8 T cells by flow cytometry | 2 YEAR | No |
Primary | the remission rate | ?bone marrow: blasts <5% (with a count of at least 200 Nucleated cells).?Hemogram: absolute neutrophil count of more than 1.0×109/L,platelets of >100×109/L. ?Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion; | 2 months | No |
Secondary | Disease Free Survival | Measured from complete remission to the date of death or the date of last follow-up examination; | 2 years | No |
Secondary | Overall Survival | measured from the Date of beginning therapy to the date of death or the date of last follow-up examination; | 2 YEAR | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |