Trial | NCT02413021  Report issue

Title

The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens
Phase 1 Study of Deferasirox in Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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).
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 .
Study Started
May 31
2016
Primary Completion
Aug 31
2016
Anticipated
Study Completion
Oct 31
2016
Anticipated
Last Update
Feb 25
2016
Estimate

Drug Cytarabine

20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle

  • Other names: Cytosar

Drug Deferasirox

20 mg/kg ,oral, per day

  • Other names: osveral

deferasirox + cytarabine Experimental

deferasirox + cytarabine group will receive oral deferasirox at 20 mg/kg per day and cytarabine at20 mg/m^2 , SC , two times a day for 10 days every 30 days for 1 cycle.

cytarabine Active Comparator

cytarabine group will receive just cytarabine at 20 mg/m^2 , SC , two times a day for 10 days every 30 days for 1 cycle.

Criteria 

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:

age > 65
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:

GFR < 40
Control group become iron overloaded (Ferritin > 500 μg /l)
Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
Not willing to continue treatment.
No Results Posted