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

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Acute Lymphoid Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Cytarabine; Drug: Deferasirox

Study type: Interventional

Funder types: Other

Identifiers

NCT02413021

78001

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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:

2. age > 65

3. existence of another illness, such as heart failure (EF> 40)

4. Ferritin < 500 μg / l

5. Not existence of other co morbidity

6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

deferasirox + cytarabine

Experimental group

Description:

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.

Treatment:

Drug: Cytarabine

Drug: Deferasirox

cytarabine

Active Comparator group

Description:

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.

Treatment:

Drug: Cytarabine