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The efficacy and safety of modified BCL2 inhibitor and azactidine for frail and older New diagnosis AML

The efficacy and safety of modified BCL2 inhibitor and azactidine for frail and older New diagnosis AML

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049931
Enrollment
Unknown
Registered
2021-08-12
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia

Interventions

1:rHuG-CSF + shorten the time of BCL2 inhibitor + Azacitidine

Sponsors

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older and a confirmed diagnosis of previously untreated AML according to World Health Organization criteria with at least one of the following conditions: 1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; 2) Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction = 30 mL/min to 1.5 to <= 3.0 ULN; 3) Patients have any other comorbidity that the physician judges to be incompatible with intensive chemotherapy; 4) patients willing to participate; 2. older than 75 years old untreate AML; 3. high-risk MDS 4. Patients should have a life expectancy of at least 12 weeks.

Exclusion criteria

Exclusion criteria: 1. Patient has received treatment with hypomethylating agent, and/or venetoclax; 2. Patient has sever liver dis-function (Child-pugh C),or renal dis-function( a creatinine <=15 mL/min) 3. physician judges to be incompatible with this treatment protocol.

Design outcomes

Primary

MeasureTime frame
ORR;overall survival;

Secondary

MeasureTime frame
CR and CRi;safety;Evevt-free survival;

Countries

China

Contacts

Public ContactJuan Huang

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

juanjuan028@126.com+8618108189376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026