The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Cytarabine
20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle
Other Names:
Drug: Deferasirox
20 mg/kg ,oral, per day
Other Names:
|
| Active Comparator: 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. |
Drug: Cytarabine
20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- complete Remission [first month]
Secondary Outcome Measures
- Partial Remission [up to four weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons:
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age > 65
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existence of another illness, such as heart failure (EF> 40)
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Ferritin < 500 μg / l
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Not existence of other co morbidity
-
GFR > 40
Exclusion Criteria:
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GFR < 40
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Control group become iron overloaded (Ferritin > 500 μg /l)
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Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
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Not willing to continue treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Isfahan University of Medical Sciences
Investigators
- Principal Investigator: Valiollah Mehrzad, MD, Seyyed-alshohada hospital of Isfahan
- Principal Investigator: Shaghayegh Haghjoo Javanmard, MD, PHD, Applied Physiology Research Center
- Principal Investigator: Mahnaz Danesh, MD, Seyyed-alshohada hospital of Isfahan
- Principal Investigator: Alireza Eishi, Med student, Applied Physiology Research Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Fukushima T, Kawabata H, Nakamura T, Iwao H, Nakajima A, Miki M, Sakai T, Sawaki T, Fujita Y, Tanaka M, Masaki Y, Hirose Y, Umehara H. Iron chelation therapy with deferasirox induced complete remission in a patient with chemotherapy-resistant acute monocytic leukemia. Anticancer Res. 2011 May;31(5):1741-4.
- Heath JL, Weiss JM, Lavau CP, Wechsler DS. Iron deprivation in cancer--potential therapeutic implications. Nutrients. 2013 Jul 24;5(8):2836-59. doi: 10.3390/nu5082836. Review.
- Paubelle E, Zylbersztejn F, Alkhaeir S, Suarez F, Callens C, Dussiot M, Isnard F, Rubio MT, Damaj G, Gorin NC, Marolleau JP, Monteiro RC, Moura IC, Hermine O. Deferasirox and vitamin D improves overall survival in elderly patients with acute myeloid leukemia after demethylating agents failure. PLoS One. 2013 Jun 20;8(6):e65998. doi: 10.1371/journal.pone.0065998. Print 2013.
- 78001