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Cladribine, homoharringtonine and cytarabine (CHA) regimen in the treatment of refractory/relapsed acute myeloid leukemia

A single center, single-arm, prospective clinical study of Cladribine, homoharringtonine and cytarabine (CHA) regimen in the treatment of refractory/relapsed acute myeloid leukemia

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-14005712
Enrollment
Unknown
Registered
2014-12-13
Start date
2014-12-05
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Acute myeloid leukemia

Interventions

Case series:Cladribine, homoharringtonine and cytarabine

Sponsors

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. To be aged 18~55 years; 2. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2; 3. Acute myeloid leukemia diagnosied by MICM criterion (rule out APL); 4. Primary AML; 5. Expected survival longer than 3 months; 6. Meets the diagnosis criterion of refractory AML: Didn't reach CR after two cycles of standard induction; With blasts/leukemic cell clearance lower than 50% after one cycle of standard induction; Relapse within 6 months after first CR; Relapse later than 6 months after first CR and didn't respond to the former induction regimen; Relapse more than 2 times; 7. Meets the diagnosis criterion of relapse AML: more than 5% blasts found in bone marrow/peripheral blood after CR(rule out other cause, consolidation etc.); 8. Bone marrow aspirtes show active proliferation and above 9. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled infection; 2. Other severe condition that patients can not tolerate chemotherapy; 3. Liver and renal insufficiency (creatinine, AST or ALT more than 2* upper normal serum level); 4. Severe neurological or psychiatric history; 5. Heart failure NYHA III/IV, severe arrhythmia, ejection fraction less than 50% by echocardiography; 6. Allergy to any drug in the CHA regimen; 7. Patients with a "currently active" second malignancy; 8. Patients underwent stem cell transplatation; 9. Patients with extra-medullary leukemia.

Design outcomes

Primary

MeasureTime frame
complete remission rate;partial remission rate;

Secondary

MeasureTime frame
Overall survival;Disease free survival;minimal residual disease;

Countries

China

Contacts

Public ContactJunmin Li
lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

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