Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Leukemia is one of the common malignant tumors that threaten human health. Although the efficacy of AML treatment has improved significantly in recent years, it remains one of the major diseases threatening human health. Current research on AML treatment mainly has two directions. One is the addition of new targeted therapy drugs, and the other research direction is to enhance the intensity of AML chemotherapy, including the use of large doses of anthracycline drugs or the use of high-dose cytarabine treatment. Since the 1990s, induction remission has been achieved by using anthracyclines in combination with high-dose cytarabine. The ECOG (Eastern Cooperative Oncology Group) contends that high-dose induction chemotherapy fails to enhance the bone marrow remission rate but elevates the chemotherapy-related mortality rate. Bradstock and the Australian Group also noted that although it does not increase the bone marrow remission rate, it can result in longer survival time and disease-free survival time. The clinical study from EORTC-GIMEMA AML-12 discovered that AML patients under the age of 45 could benefit from induction therapy incorporating high-dose cytarabine. In our previous randomized controlled clinical trials, it was found that the HAD and DA regimens containing intermediate-dose cytarabine could enhance the complete remission rate and improve the overall survival of adult AML. However, the degree of benefit varies among different AML subgroups. The abnormalities of RUNX1-RUNX1T1 and CBFβ-MYH11 respectively involve a subunit of CBF (core binding factor), thus the two are collectively called CBF leukemia. Previous retrospective studies show that this type of leukemia benefits from intensified treatment regimens such as FLAG. However, at present, there is a lack of prospective randomized controlled clinical studies to confirm this. Therefore, in this study, we intend to further verify through a prospective randomized controlled clinical trial whether the induction treatment regimen containing intermediate-dose cytarabine can improve the long-term efficacy of adult RUNX1-RUNX1T1 acute myeloid leukemia.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza białaczki szpikowej potwierdzona wg standardów WHO lub ICC
- •Obecność genetycznego zaburzenia RUNX1-RUNX1T1 w komórkach leukemicznych
- •Wiek 14-60 lat
- •Ogólny stan zdrowia oceniony na 0-2 w skali ECOG
- •Prawidłowe wyniki badań wątroby (bilirubina, enzymy wątrobowe)
- •Prawidłowe wyniki badań nerek
- •Prawidłowa funkcja serca (frakcja wyrzutowa >50%)
- •Podpisana świadoma zgoda pacjenta lub opiekuna prawnego
✗ Disqualifies
- •Białaczka promielocytarna (z mutacją PML-RARA)
- •Białaczka z mutacją BCR-ABL
- •Pacjenci już wcześniej leczeni na tę chorobę
- •Jednoczesne występowanie innego nowotworu wymagającego leczenia
- •Aktywne choroby serca: niekontrolowana choroba wieńcowa, zawał w ostatnich 6 miesiącach, zaburzenia rytmu serca
- •Nieuleczone ciężkie infekcje
Simplified criteria — AI translation
Trial details
- Minimum age
- 14 Years
- Maximum age
- 60 Years
- Last updated (source)
- August 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Blood Diseases Hospital
Tianjin, China
Trial contact
Hui Wei, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/8/2026.
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