Skip to content

A Bcl-2 Inhibitor Resistance Disease-Syndrome Model and an Evidence-Based Evaluation of the Sensitizing Effect of Shiwei Xiaobai Decoction (SWXB) in Elderly Unfit AML

A Bcl-2 Inhibitor Resistance Disease-Syndrome Model and an Evidence-Based Evaluation of the Sensitizing Effect of Shiwei Xiaobai Decoction (SWXB) in Elderly Unfit AML

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000760
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Elderly unfit acute myeloid leukemia

Interventions

Hom+reduced-dose VA:Homoharringtonine + Venetoclax + Azacitidine
SWXB+reduced-dose VA:Shiwei Xiaobai Decoction + Venetoclax + Azacitidine
Standard VA:Venetoclax + Azacitidine

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.The diagnosis is consistent with AML. 2.Aged 60 to 80 years old (inclusive) 3.Intolerant to standard-intensity induction chemotherapy, without severe comorbidities (ECOG performance status = 2) 4.No prior treatment with Bcl-2 inhibitors 5.Complete data on molecular genetic stratification and prognostic evaluation are available 6.A systematic assessment of drug resistance has been completed

Exclusion criteria

Exclusion criteria: 1.Patients with myeloproliferative neoplasms, including myelofibrosis, chronic leukemia, etc. 2.Hybrid or mixed phenotype acute leukemia 3.Individuals diagnosed in Traditional Chinese Medicine as having deficiency and decline of the spleen and kidney, and therefore unable to tolerate the nature and flavor of this Chinese herbal medicine. Symptoms include abdominal distension, loose stools, aversion to cold, cold limbs, deep-thready-weak pulse, etc. 4.Inability to take Chinese herbal medicine or allergy to Chinese herbal medicine.

Design outcomes

Primary

MeasureTime frame
Resistance free survival (RFS);

Secondary

MeasureTime frame
Response rate;MRD negativity conversion rate;Intensive chemotherapy consolidation rate;

Countries

China

Contacts

Public ContactWu Dijing

Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

wudijiong@zcmu.edu.cn139 8946 3963

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026