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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Phase 1 Study of Deferasirox in Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens

Conditions
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Acute Myeloid Leukemia, Acute Lymphoid Leukemia

Intervention / Treatment
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* Drug: Cytarabine
* Drug: Deferasirox


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deferasirox + cytarabine<br>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. | Drug: Cytarabine<br>* 20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle<br>* Other names: Cytosar;Drug: Deferasirox<br>* 20 mg/kg ,oral, per day<br>* Other names: osveral;|
| Active Comparator: cytarabine<br>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. | Drug: Cytarabine<br>* 20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle<br>* Other names: Cytosar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete Remission |  | first month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Remission |  | up to four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Acute Lymphoid Leukemia, deferasirox