A Phase 2 interventional study of Decitabine for Injection and VENCLYXTO in Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
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Among 121 studies testing decitabine in Leukemia, Myeloid, Acute — 20 open to participants now, 33 under way, 2 of them phase 3. Decitabine · Leukemia, Myeloid, Acute.
Among the 121 studies testing decitabine in Leukemia, Myeloid, Acute, this one is the 18th largest by planned enrollment of the 120 interventional ones that give a count, is one of 4 that started in 2023, is one of 53 in phase 2, reaches primary completion later than 9 of the 32 other live ones, and was the 106th registered.
3,668 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
Browse Leukemia, Myeloid, Acute studies →20 of the 121 studies testing decitabine in Leukemia, Myeloid, Acute are open now, in 5 countries. Recruiting first, the newest first:
PETHEMA Foundation · Sites in Portugal, Spain
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages up to 21
The Methodist Hospital Research Institute · Sites in United States
Ages 18+
David Avigan · Sites in United States
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Healthy volunteers
By country, each count listing its studies:
Decitabine: first FDA approval 2006 (DACOGEN), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 625 Leukemia, Myeloid, Acute studies recruiting now, 363 (58%) set no upper age limit and 222 (36%) stop at 75 or younger; 145 take children under 18; 29 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 72 · Phase 3 13 · Phase 4 2
First in 1995; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 40 across 3,006 interventional studies indexed under Leukemia, Myeloid, Acute.
Median enrollment 32 across the 120 interventional studies. Of the 67 that completed or were terminated, 39 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 121 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital of Zhejiang University is the lead sponsor of 264 studies on the registry; 145 are open to participants now.
16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University: 15 open now, 15 under way, 2 of them phase 3. Of 1 finished, 0 (0%) have results posted.
Among the 16 studies in Leukemia, Myeloid, Acute by First Affiliated Hospital of Zhejiang University, this one is the 6th largest by planned enrollment, is the only one that started in 2023, is one of 9 in phase 2, reaches primary completion later than 1 of the 14 other live ones, and was the 1st registered.
First Affiliated Hospital of Zhejiang University’s Leukemia, Myeloid, Acute studies by the year they started, since 2022.
6 of the studies testing decitabine in Leukemia, Myeloid, Acute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06129734Benjamin TomlinsonDecitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant | 2027-03 |
| NCT05190471Bio-Path Holdings, Inc.A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML) | 2027-03 |
| NCT05222984City of Hope Medical CenterNavitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax | 2027-03-02 |
| NCT07012044National Cancer Institute (NCI)A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia | 2027-03-31 |
| NCT07374029David AviganAdoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML | 2027-10-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 121 studies testing decitabine in Leukemia, Myeloid, Acute, from their registry updates:
Among First Affiliated Hospital of Zhejiang University’s 16 in Leukemia, Myeloid, Acute:
This tab as a report to print or save as PDF → With an account.
To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.
In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.
However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.
Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.
The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission.
Diagnostic criteria refer to 2016 WHO classification.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acute Myeloid Leukemia Myelodysplastic Syndrome
Drug: Decitabine for Injection · Drug: VENCLYXTO
6mg/m2, ivgtt qd d1-10
Also known as: Dacogen, 5-Aza-29-deoxycytidine
100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration
Also known as: VENLEXTA
Complete response rate(CR+CRi)
Assessment of CR(CR=CR+CRi) at Week 8
Time frame: at Week 8
MRD
Assessment of minimal residual disease (MRD) at Week 8
Time frame: at Week 8
EFS
Evaluation of Event-free survival (EFS)
Time frame: up to 2 years after induction therpy
OS
Evaluation of overall survival (OS)
Time frame: up to 2 years after induction therpy
Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.
Of 386 non-industry phase 2 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 24 months is below that.
Counting every sponsor, half of 443 studies reached it within 60 months; a quarter within 38 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Decitabine · Venetoclax
First Affiliated Hospital of Zhejiang University →