Acute Lymphoid Leukemia, Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, Acute Lymphoid Leukemia, deferasirox
Brief summary
The purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).
Detailed description
Many studies have demonstrated that Iron is essential for the metabolism, cell cycle regulation and metastasis in different cancer cell lines. It is also believed that Iron concentration will increase in cancer cells by enhancing expression of TFR-1 receptors and in case of receptor saturation, non-receptor-mediated pinocytosis would be a significant pathway for more iron intake. Iron deficiency may lead to increase P 53 which consequently will stop cell mitosis in G1-S state. It also increases expression of N-myc down-regulated gene 1 which can suppress metastasis in cancer. It has been suggested that Iron chelators may decrease leukemic tumor growth in animal models of acute myeloid leukemia (AML). Some other case studies demonstrated the role of Iron chelators in relapse and/or refractory AML. Finally a phase 1 clinical study is undertaken for evaluate the role of Tiapine and cytarabine for adult AML and high-risk myelodysplastic syndrome. So in this study the investigators try to evaluate the role of iron chelating agent (deferasirox) for patients with acute lymphatic leukemia (ALL) and AML patients who cannot be treated with standard chemotherapy regimes .
Interventions
DRUGCytarabine
20 mg/m\^2 , SC, two times a day for 10 days every 30 days for 1 cycle
DRUGDeferasirox
20 mg/kg ,oral, per day
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons: 1. age \> 65 2. existence of another illness, such as heart failure (EF\> 40) 2\. Ferritin \< 500 μg / l 3\. Not existence of other co morbidity 4\. GFR \> 40
Exclusion criteria
1. GFR \< 40 2. Control group become iron overloaded (Ferritin \> 500 μg /l) 3. Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea) 4. Not willing to continue treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete Remission | first month |
Secondary
| Measure | Time frame |
|---|---|
| Partial Remission | up to four weeks |
Contacts
Primary ContactMahnaz Danesh, MD
Backup ContactAlireza Eishi, Med student
Outcome results
None listed