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The clinical study of induction therapy in elderly acute myeloid leukemia patients who are unfit for standard chemotherapy

The clinical study of induction therapy in elderly acute myeloid leukemia patients who are unfit for standard chemotherapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17011677
Enrollment
Unknown
Registered
2017-06-16
Start date
2017-06-19
Completion date
Unknown
Last updated
2017-06-19

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

Conditions

AML

Interventions

A:HAG regimen
B:decitabine

Sponsors

Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed elderly AML is confirmed by bone marrow morphology and immunology assay; 2. APL is excluded by bone marrow morphology or molecular level tests; 3. Patient aged between 60 to 75 years; 4. Patient meets the conditions of Pre-treatment risk assessment stratification scale ("unfit" group) for elderly AML (non-M3); 5. Obtained an Informed Consent Form signed by patient or their families.

Exclusion criteria

Exclusion criteria: 1. APL patients; 2. Re-treated patient; 3. Allergy to any drug presented in study protocol; 4. Obvious contraindications to anthracycline chemotherapy drugs; 5. Patient meets the conditions of "not suitable" and "suitable chemotherapy" in the Pre-treatment risk assessment stratification scale for elderly AML (non-M3); 6. Unable to understand or comply with the study protocol; 7. Previous intolerance or allergy to the similar drugs; 8. Patients below the age of 60 or over 75 (60 and 75 are not included); 9. Participating in other clinical investigation simultaneously; 10. Having any issue that may hinder the clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Disease Free Survival;

Secondary

MeasureTime frame
Complete Remission;Early Death Rate;Toxicity and Safety;Minimal residual disease;

Countries

China

Contacts

Public ContactJunmin Li

Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

lijunmin@medmail.com.cn+86 13817712211

Outcome results

None listed

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