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

Phase 1

• Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia
• Interventions: Drug: Cytarabine; Drug: Deferasirox

• Registration Number: NCT02413021
• Lead Sponsor: Isfahan University of Medical Sciences

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 .

Study Timeline

• Study First Submitted: 2015-01-10
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25
• Study Start: 2016-05
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deferasirox + cytarabine	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.
deferasirox + cytarabine	Deferasirox	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	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.

Primary Outcome Measures

Name	Time	Method
complete Remission	first month

Secondary Outcome Measures

Name	Time	Method
Partial Remission	up to four weeks