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

Summary

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.

Timeline

Start

2015-09-17

Primary completion

2022-04-05

Completion

2024-01-12

Publications

• Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, Muller LP, Schmid C, Krause SW, Bethge W, Jost E, Platzbecker U, Klein SA, Niederland J, Kaufmann M, Schafer-Eckart K, Baldauf H, Stolzel F, Trost S, Rollig C, von Bonin M, Egger-Heidrich K, Kunadt D, Steffen B, Hauptrock B, Schliemann C, Sockel K, Lang F, Kriege O, Schaffrath J, Reicherts C, Berdel WE, Serve H, Ehninger G, Schmidt AH, Mikesch JH, Bornhauser M, Schetelig J. Disease risk but not remission status determines transplant outcomes in AML: long-term outcomes of the ASAP trial. Blood. 2025 Nov 6;146(19):2293-2305. doi: 10.1182/blood.2025028730.
• Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, Muller LP, Schmid C, Krause SW, Bethge W, Jost E, Platzbecker U, Klein SA, Schubert J, Niederland J, Kaufmann M, Schafer-Eckart K, Schaich M, Baldauf H, Stolzel F, Petzold C, Rollig C, Alakel N, Steffen B, Hauptrock B, Schliemann C, Sockel K, Lang F, Kriege O, Schaffrath J, Reicherts C, Berdel WE, Serve H, Ehninger G, Schmidt AH, Bornhauser M, Mikesch JH, Schetelig J; Study Alliance Leukemia and the German Cooperative Transplant Study Group. 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. Lancet Haematol. 2024 May;11(5):e324-e335. doi: 10.1016/S2352-3026(24)00065-6. Epub 2024 Apr 4.

Drugs

Indications