All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy
Mutation testing in AML:
What you need to know
with Charles Craddock, Ralph Hills, and Gail Roboz
Wednesday, April 23, 2025
17:30-18:30 BST
This independent educational activity is supported by Thermo Fisher Scientific. All content is developed independently by the faculty. The funder is allowed no influence on the content.
The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Salvage chemotherapy to induce remission prior to allo-HSCT vs immediate transplant in patients with R/R AML
Bookmark this article
Allogeneic hematopoietic stem cell transplant (allo-HSCT) is currently the only treatment that offers long-term disease-free survival in patients with relapsed/refractory acute myeloid leukemia. However, the impact of therapeutic interventions to induce complete remission prior to allo-HSCT has never been fully evaluated in randomized trials.
Recently, Stelljes et al.1 published results from the phase III ASAP trial (NCT02461537) in Lancet Hematology, comparing disease control strategies and immediate allo-HSCT vs standard salvage chemotherapy to induce remission prior to allo-HSCT. We summarize the key results below.
Study design1
-
In this open-label, multicenter, randomized controlled trial, patients in the remission induction group received high-dose cytarabine (3 g/m2 twice daily on Days 1–3) and mitoxantrone (10 mg/m2 on Days 3–5); patients in the disease control group proceeded to allo-HSCT as soon as possible.
-
The primary endpoint was the rate of treatment success, defined as complete remission on Day 56 post allo-HSCT.
-
The key secondary endpoint was overall survival from randomization.
Key findings1
-
A total of 281 patients were enrolled:
-
141 in the remission induction group; and
-
140 in the disease control group.
-
The median follow up was 37 months.
-
In the per-protocol population (n = 272), treatment success was achieved by more patients in the disease control group than in the remission induction group (84% vs 81%; p = 0.047).
-
Survival outcomes were comparable in the intent-to-treat population for patients treated with remission induction or disease control (Figure 1).
Figure 1. Survival outcomes for patients with relapsed/refractory AML treated with salvage chemotherapy before allo-HSCT or disease control and immediate allo-HSCT (intention-to-treat population)*
AML, acute myeloid leukemia; allo-HSCT, allogeneic hematopoietic stem cell transplant; CIR, cumulative incidence of relapse; CR, complete remission; LFS leukemia-free survival; NRM, non-relapse mortality; OS, overall survival.
*Adapted from Stelljes, et al.1
†Estimated difference in treatment success was 3.4%.
Non-inferiority could not be shown at the 2.5% significance level.
Safety
-
Non-hematological Grade ≥3 adverse events were more frequent in the remission induction group vs the disease control group (61% vs 21%; p < 0.0001).
-
The most common event across both groups was infection (55% vs 16%; p < 0.0001).
-
The cumulative incidence of Grade 2–4 acute graft-versus-host disease at Day 120 post HSCT was comparable between the induction remission and disease control groups in the per-protocol population (21% vs 22%, p = 0.74).
-
Within 28 days, 6 patients died in the remission induction group and 8 patients from the disease control group (p = 0.65).
|
Key learnings |
|
- Stelljes M, Middeke J, Bug G, et al. Remission induction versus immediate allogeneic hematopoietic stem cell transplantation for patients with relapsed or poor responsive acute myeloid leukemia (ASAP): a randomized, open-label, phase 3, non-inferiority trial. Lancet Hematol. 2024. Online ahead of print. DOI: 10.1016/S2352-3026(24)00065-6
Your opinion matters
3 votes - 20 days left ...
Newsletter
Subscribe to get the best content related to AML delivered to your inbox