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Ara-C, ACR, and GM-CSF (CAGM ) as a Salvage Regimen in Patients With Relapsed /Refractory Acute Myelomonocytic or Monocytic Leukemia

Ara-C, ACR, and GM-CSF (CAGM ) as a Salvage Regimen in Patients With Relapsed /Refractory Acute Myelomonocytic or Monocytic Leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041011
Enrollment
Unknown
Registered
2020-12-16
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Relapsed/Refractory Acute Myelomonocytic or Monocytic Leukemia

Interventions

CAGM:CAGM
CAG:CAG

Sponsors

The First Afliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with M4/M5 diagnosed according to FAB criteria, with or without genetic/chromosomal abnormalities. 2. relapse criteria: recurrence of leukemic cells in peripheral blood or bone marrow primitive cells 5% after CR (other causes need to be excluded such as bone marrow reconstruction after chemotherapy) or extra-marrow infiltration of leukemic cells. 3. refractory AML refers to those who have not achieved CR after 2 courses of standard regimen induction chemotherapy; relapse within 12 months after the 1st complete remission; relapse after 12 months after the 1st CR and failure of re-induction chemotherapy by the original regimen; >= 2 relapses or persistence of extramedullary leukemia. 4. age between 18 and 75 years, male or female. 5. ECOG physical score of 0-3. 6. expected survival time > 3 months. 7. have not received chemotherapy within 4 weeks before enrollment; voluntarily signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of clinically significant QTc interval prolongation (>450ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year of onset, congestive heart failure (CHF), and patients with symptomatic coronary heart disease requiring drug therapy. 2. patients with end-diastolic pericardial cavity fluid dark areas >= 10 mm in width on cardiac ultrasound. 3. patients who have received pre-stimulated regimen chemotherapy or organ transplantation. 4. patients in the acute phase with thrombosis, embolism, cerebral hemorrhage, cerebral infarction, etc. 5. patients who have not completed 6 weeks after surgery of a vital organ. 6. patients with abnormal liver function (total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal or ALT/AST > 5 times the upper limit of normal in patients with liver invasion), abnormal renal function (serum creatinine > 1.5 times the upper limit of normal), and abnormal electrolyte metabolism. 7. persons with mental disorders/unable to obtain informed consent. 8. patients with drug addiction, chronic alcohol abuse such that it affects the evaluation of the test results. 9. those who are judged by the investigator to be unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Efficiency;

Countries

China

Contacts

Public ContactLiu limin

The First Afliated Hospital of Soochow University

liminliu2006@163.com+86 15262482466

Outcome results

None listed

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