NCT02461537: ETAL3-ASAP

Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML

Completed Phase 3 Last updated 19 January 2024

What this trial tests

Phase 3 trial testing HAM in Acute Myeloid Leukemia in 281 participants. Completed in 12 January 2024.

Timeline

17 September 2015

Primary endpoint
5 April 2022

12 January 2024

Quick facts

Lead sponsor	DKMS gemeinnützige GmbH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	281
Start date	17 September 2015
Primary completion	5 April 2022
Estimated completion	12 January 2024
Sites	18 locations across Germany

Drugs / interventions tested

• HAM — full drug profile →
• LDAC and/or Mitoxantrone — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

DKMS gemeinnützige GmbH — full company profile →

Who can join

Adults 18 to 75, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. The standard strategy is aimed at achieving a complete remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, . The alternative is a less toxic disease-control strategy of disease monitoring and, if necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which should be performed as soon as possible.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remission induction versus immediate allogeneic haematopoietic stem cell transplantation for patients with relapsed or poor responsive acute myeloid leukaemia (ASAP): a randomised, open-label, phase 3, non-inferiority trial.
   Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, et al · · 2024 · cited 37× · PMID 38583455 · DOI 10.1016/s2352-3026(24)00065-6
2. Prognostic relevance of remission and measurable residual disease status in AML patients prior to reduced intensity or non-myeloablative allogeneic stem cell transplantation.
   Jentzsch M, Grimm J, Bill M, Brauer D, et al · · 2021 · cited 21× · PMID 33927190 · DOI 10.1038/s41408-021-00471-x
3. Allogeneic Stem Cell Transplantation with Sequential Melphalan-Based Conditioning in AML: Residual Morphological Blast Count Determines the Risk of Relapse.
   Sockel K, Stölzel F, Hönl F, Baldauf H, et al · · 2022 · cited 7× · PMID 35210852 · DOI 10.2147/cmar.s339846
4. Effective Immunosurveillance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia.
   Kunadt D, Stölzel F. · · 2021 · cited 3× · PMID 34594134 · DOI 10.2147/cmar.s261721
5. Disease risk but not remission status determines transplant outcomes in AML: long-term outcomes of the ASAP trial.
   Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, et al · · 2025 · cited 2× · PMID 40737595 · DOI 10.1182/blood.2025028730
6. Lack of disease control remains a major barrier to transplant for older patients with AML.
   Jeng MY, Kong D, Rajalingam R, Lin RJ, et al · · 2023 · cited 1× · PMID 37353571 · DOI 10.1038/s41409-023-02022-3