HMN 2026: How Combination therapy shows promising efficacy in aggressive leukemia

Acute myeloid leukemia (AML) is a particularly aggressive form of blood cancer that usually progresses rapidly if swift and intensive treatment is not applied. Although the disease can often be contained by chemotherapy (remission), it returns in many patients. A permanent cure is often only possible with a stem cell transplant—provided that the leukemia can be sufficiently contained beforehand.

A new Germany-wide study led by Dresden University Medicine has shown that the combination of intensive chemotherapy and the substance venetoclax can significantly improve the success rate of treatment of aggressive acute leukemia. This has been confirmed by the results of RELAX, with remission in 75% of the cases compared to the past attempts yielding only a 40% remission rate. The study was published in the journal The Lancet Haematology.

“If AML stops responding to conventional intensive chemotherapy or comes back, the chances of a long-term cure decrease significantly,” explains Prof. Christoph Röllig, Head of Hematology and Clinical Trials at Medical Clinic 1 of the University Hospital Dresden and the Faculty of Medicine at TUD Dresden University of Technology. In this case, we aim to provide patients with a potentially curative stem cell transplant. “By this time, however, it can be difficult to catch the fast-growing AML with chemotherapy.”

With conventional treatments, only around 40% of those affected manage to suppress acute myeloid leukemia to such an extent that a so-called complete remission is achieved, i.e., the disease is below the detection limit and the blood count recovers.

Alongside his colleague Dr. Leo Ruhnke, Röllig designed and supervised the RELAX study—an early phase 1/2 study. The researchers investigated whether the combination of standard therapy with cytarabine and mitoxantrone (HAM) alongside the so-called BCL2 inhibitor venetoclax can improve the success rate of such therapy. As a first step, Röllig and Ruhnke’s research team tested the tolerability in the RELAX study; in a second step, they tested the efficacy of the HAM and venetoclax (“HAM-Ven”) combination.

“With the novel HAM-Ven combination, we increased the remission rates previously observed with conventional chemotherapy from 40% of patients with relapsed AML to 75%. The majority of those treated were able to successfully receive a stem cell transplant,” reports Ruhnke, senior hematologist and first author of the publication. The therapy also works well for particularly persistent, genetic forms of AML.

“The current results indicate an encouragingly good prognosis for the patients treated in the study,” says Prof. Martin Bornhäuser, Director at Medical Clinic I, member of the Directorate of the National Center for Tumor Diseases (NCT/UCC) Dresden and Professor at TU Dresden. “The RELAX study shows how academic, clinical research in cooperation with industrial partners can significantly improve the treatment of cancer.”

“The innovative treatment approach is already reaching those affected,” says Röllig. “Together with colleagues from Munster, we are currently analyzing the results of more than 150 additional AML patients who were treated in Germany with the HAM-Ven regimen after the end of the study’s recruitment period. The initial data are promising.”

The new therapy developed in Dresden therefore has a strong chance of establishing itself as a new standard of care for relapsed AML and as a bridge to a life-saving stem cell transplant, thereby improving patients’ chances of recovery.

“The RELAX study illustrates how scientific excellence and clinical expertise go hand in hand in Dresden to develop innovative therapies,” explains Prof. Esther Troost, Dean of the Faculty of Medicine at TU Dresden: “It is only through these kinds of studies that we can ensure the safety and efficacy of new treatment approaches.”

“The results of the RELAX study mark a significant leap forward, as they provide us with new and effective options to better prepare patients for a life-saving stem cell transplantation,” says Prof. Uwe Platzbecker, Medical Director of Dresden University Hospital.

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