Clinical trial NCT02413021: The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens
Official title: Phase 1 Study of Deferasirox in Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Keywords: Acute Myeloid Leukemia
Acute Lymphoid Leukemia
deferasirox
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: complete Remission
timeFrame: first month
Secondary outcomes:
measure: Partial Remission
timeFrame: up to four weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seyyed-alshohada hospital of Isfahan
name: Valiollah Mehrzad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Applied Physiology Research Center
name: Shaghayegh Haghjoo Javanmard, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seyyed-alshohada hospital of Isfahan
name: Mahnaz Danesh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Applied Physiology Research Center
name: Alireza Eishi, Med student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.