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Retrospective study of realgar-indigo naturalis formula in the treatment of patients with relapsed and arsenic trioxide-resistant acute promyelocytic leukemia

Retrospective study of realgar-indigo naturalis formula in the treatment of patients with relapsed and arsenic trioxide-resistant acute promyelocytic leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200065047
Enrollment
Unknown
Registered
2022-10-26
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

acute promyelocytic leukemia

Interventions

Case series:N/A

Sponsors

PLA 967th Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The eligibility criteria of relapsed and arsenic trioxide-resistant acute promyelocytic leukemia: ATO resistance was defined as failure to achieve HCR or progress to hematologic relapse during ATO-based therapy. Leukemia relapse was defined as one of the following: (1) 6–20% blasts and promyelocytes in bone marrow and lack of hematologic complete remission after anti-leukemia treatment, (2) > 20% blasts and promyelocytes in bone marrow, or (3) extramedullary infiltration of leukemia. Morphologic diagnosis of acute promyelocytic leukemia according to French-American-British criteria. 2.Demonstration of PML-RARa fusion transcripts by RT-PCR or cytogenetic demonstration of t(15;17)(q22;q12). 3. Eastern Cooperative Oncology Group performance status 0–3. 4. Age >18 years. 5. Normal left ventricular ejection fraction and Q-Tc interval <500 ms. 6.No history of cancer, other than basal cell skin cancer or cervical carcinoma in situ. 7.Creatinine concentration <= 3 times the institutional upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase concentrations <= 2.5 times the ULN, and bilirubin concentration <= 2 times the ULN. 8. Written informed consent from legal guardians.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or lactating women 2. Concomitant severe psychiatric condition, or patients with severe primary diseases of heart, brain, kidney and other organs. 3. Poor medication compliance, taking medicine irregularly, or taking other drugs that may affect the effect of anti-leukemia drugs. 4. Data imperfection, unable to determine efficacy and safety.

Design outcomes

Primary

MeasureTime frame
complete remission rate;Overall Survival;

Countries

China

Contacts

Public ContactChen Nannan

PLA 967th Hospital

jlqtcmcnn@163.com+86 411 80841235

Outcome results

None listed

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