Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
NCT Number: NCT06744556
Acute myeloid leukemia (AML) is the most common leukemia in China, with a high incidence in elderly patients (≥60 years), who comprise over half of all cases (median age ~68 years). Elderly AML patients have a poor prognosis and carry multiple high-risk factors, with a 5-year overall survival (OS) of only 3-8%.
Before the era of novel targeted agents, the classic "3+7" regimen was the standard intensive chemotherapy for eligible elderly patients, yielding an induction complete remission (CR) rate of 40-60%. Long-term survival remained poor, as most elderly patients are not candidates for allogeneic hematopoietic stem cell transplantation.
Recent clinical studies have shown that combinations of novel targeted agents with hypomethylating agents improve outcomes in elderly or unfit patients. In a previously initiated multicenter, prospective, randomized controlled trial (NCT06066242), the investigators aimed to identify the optimal induction regimen for elderly fit patients with newly diagnosed AML. Preliminary data indicate that the DNR/IDA + Ara-C + venetoclax (DAV/IAV) regimen achieved a higher induction remission rate (77.3%) compared with DA/IA (3+7) or Ven + azacitidine (45-59%). However, this rate remains below that observed in younger adults (>85%), highlighting the need for further optimization.
This study is active but is not currently recruiting participants.
Notify Me60 year–75 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300020, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Used in combination with cytarabine and venetoclax for induction therapy in DAV.
Used in combination with cytarabine and daunorubicin for induction therapy in DAV.
Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.
Used in combination with venetoclax for maintenance therapy.
Used in combination with cytarabine and venetoclax for induction therapy in HAV.
Used in combination with cytarabine and venetoclax for induction therapy in IAV.
Time frame: Up to approximately 1 years after the date of the last enrolled participants
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first)
Time frame: Up to approximately eight weeks afer induction therapy
Proportion of patients with CR, CRh or CRi
Time frame: Up to approximately eight weeks afer induction therapy
Among those who have achieved CR/CRh/CRi after induction, proportion of patients who is undectable MRD by flow cytometry
Time frame: up to 1 years after the date of the last enrolled participants
Among those who have achieved CR/CRh/CRi in the whole treatment, proportion of patients who is undectable MRD by flow cytometry
Time frame: Up to approximately 1 years after the date of the last enrolled participants
It is defined as the time from the start of achieving remission to disease progression, death from any cause or the last follow-up.
Time frame: Up to approximately 30 days
It is defined as death from any cause within 30 days after the start of induction.
Time frame: Up to approximately 60 days
It is defined as death from any cause within 60 days after the start of induction.
Time frame: up to 1 years after the date of the last enrolled participants
The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first.
Institute of Hematology & Blood Diseases Hospital, China
Other
HAV Versus DAV/IAV Induction Regimen in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy: a Multicenter, Randomized, Controlled Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03739502
ALL, AML
Rochester, New York, United States
View Trial DetailsNCT06664879
AML
Houston, Texas, United States
View Trial DetailsNCT05226455
AML, MDS
Angers, France
View Trial DetailsNCT05199051
AML, Disease Attributes
Amiens, France
View Trial Details