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Your journey
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More info
You can access this
clinical trial
if you have
Acute Myeloid Leukemia
and you are
between 18 and 60
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is the standard consolidation therapy for these patients with a 5-year overall survival approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation, maintenance therapy is performed with conventional chemotherapy with a 5-year overall survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine was also reported by several studies. In this study, the investigators plan to carry out a prospective, multicenter, randomized, controlled trail to compare decitabine versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results of this trial may optimize the treatment for AML patients with t(8;21) in the setting of intermediate dose cytarabine consolidation.

Provided treatments

  • Drug: Decitabine
  • Drug: Daunorubicin, Cytarabine
  • Drug: Mitoxantrone, Cytarabine
  • Drug: Aclacinomycin, Cytarabine
Tris trial is registered with FDA with number: NCT03026842. The sponsor of the trial is First Hospital of Jilin University and it is looking for 180 volunteers for the current phase.
Official trial title:
A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)