A prospective multicenter randomized controlled study of compound Zhebei granules combined with VA regimen in the treatment of relapsed and refractory AML

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084082

Enrollment

Unknown

Registered

2024-05-10

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Refractory/Relapsed acute myeloid leukemia, R/R AML

Interventions

Experimental group:VEN 100mg d1,200mg d2,400mg d3-28 (bone marrow re-examination at d14, and later medication duration adjustment), oral administration. AZA 75mg/(m2·d),d1-7, subcutaneous injection. U

Control group:VEN 100mg d1,200mg d2,400mg d3-28 (bone marrow re-examination at d14, and later medication duration adjustment), oral administration. AZA 75mg/(m2·d),d1-7, subcutaneous injection. Dosage

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Simultaneously meet the following 6 criteria: ? Age 18-75 years old; ? Meet the diagnostic criteria for Refractory/Relapsed acute myeloid leukemia; ? Meet the diagnostic criteria for phlegm stasis obstruction syndrome; ? Individuals who cannot tolerate or refuse to receive strong chemotherapy; ? Individuals who have no indications for targeted drugs or refuse to receive targeted drug treatment; ? Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: Meet any one of the following criteria: ? Early recurrence after previous treatment with VEN+HMA; ? Patients with other severe hematological or non-hematological malignancies; ? Individuals with severe organic lesions such as cardiovascular, cerebrovascular, liver, and kidney; ? Pregnant or lactating women; ? Patients with mental illnesses who cannot cooperate with treatment; ? Patients participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Objective response rate;	—

Secondary

Measure	Time frame
Evaluation of Traditional Chinese Medicine Syndrome Efficacy;Patient Report Outcome AcuteLeukemia,ALPRO;MRD negative conversion rate;Progression-free survival;Relapse-free survival;Overall survival rate;	—

Countries

China

Contacts

Public ContactLang Haiyan

Tongzhou Campus of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

julietlang@126.com+86 138 1068 0199

Outcome results

None listed

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