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Clinical study on the intervention of kidney tonifying and detoxifying herbs in the peri-chemotherapy period of acute myeloid leukemia in the elderly

Clinical study on the intervention of kidney tonifying and detoxifying herbs in the peri-chemotherapy period of acute myeloid leukemia in the elderly

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052019
Enrollment
Unknown
Registered
2021-10-13
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Acute myeloid leukemia

Interventions

Control group:Placebo
Intervention group:Kidney tonifying and detoxifying herbs

Sponsors

Tongren Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the 2016 WHO diagnostic criteria for acute myeloid leukemia: peripheral blood and bone marrow primitive cells >= 20% or clonally recurrent genetic abnormalities t(8; 21)(q22; q22), inv16 (p13; q22) or t(16; 16)(p13; q22) and PML-RARA alpha, with primitive cells = 60 years; 3. Indication for chemotherapy; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 5. No serious organ function abnormalities and the following test criteria: ALT, AST, TBIL = 55% by echocardiography; 6. Ability to understand and voluntarily give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to chemotherapy; 2. Pregnant or lactating women; 3. Patients with allergies to any of the drugs used in the study protocol; 4. Patients who are unable to sign informed consent due to mental retardation or psychiatric disorders; 5. Patients with other serious comorbidities such as severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc., which in the judgment of the investigator would affect the study and make them unsuitable for enrollment; 6. Patients who participated in other relevant clinical studies during the same period or within 1 month prior to enrollment.

Design outcomes

Primary

MeasureTime frame
Bleeding score;

Secondary

MeasureTime frame
Post-induction response (complete remission and partial remission) rate;Early death rate;Imported blood production;Infection incidence;

Countries

China

Contacts

Public ContactLiu Ligen

Tongren Hospital, Shanghai Jiaotong University School of Medicine

2512034560@qq.com+86 18017337037

Outcome results

None listed

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