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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

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).

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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 .

Conditions

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Acute Myeloid Leukemia Acute Lymphoid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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deferasirox + cytarabine

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.

Group Type EXPERIMENTAL

Cytarabine

Intervention Type DRUG

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

Deferasirox

Intervention Type DRUG

20 mg/kg ,oral, per day

cytarabine

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.

Group Type ACTIVE_COMPARATOR

Cytarabine

Intervention Type DRUG

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

Interventions

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Cytarabine

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

Intervention Type DRUG

Deferasirox

20 mg/kg ,oral, per day

Intervention Type DRUG

Other Intervention Names

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Cytosar osveral

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:

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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No