Know Cancer

or
forgot password

Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule


Phase 2
60 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Acute

Thank you

Trial Information

Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule


Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone
marrow plus incomplete differentiation. Many of this patients are elderly with age further
than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard
therapy of this patients is high that can reach to 50%. One of methods to apply a remission
with least mortality and morbidity and also significant lower cost effects compare to
historical and conventional standard regimen is low dose cytosar and arsenic trioxide
combination that has been reported complete remission to 34%.

We select ten patients with age further than 60 with comorbidity and treat by low dose
cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall
response rate and overall survival in end of one year.


Inclusion Criteria:



- Elderly patients with non promyelocytic AML

- Performance status (ECOG) 3 or 4

Exclusion Criteria:

- Age <60 years

- Elevation of AST OR ALT more than ten times above normal

- Serum bilirubin above 5

- Cr level > 2

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

1, 2, 6 month and one year after intervention

Safety Issue:

No

Principal Investigator

Kamran Alimoghaddam, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Hematology-Oncology and SCT Research Center

Authority:

Iran: Ministry of Health

Study ID:

87-02-36-7242

NCT ID:

NCT00850304

Start Date:

October 2007

Completion Date:

February 2008

Related Keywords:

  • Leukemia, Myeloid, Acute
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location