"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 Haematology 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 percent 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, Christoph 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 percent of patients with relapsed AML to 75 percent. The majority of those treated were able to successfully receive a stem cell transplant," reports Leo 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 Christoph 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 is 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.
About the study
The study project was designed under the sponsorship of the Faculty of Medicine at TU Dresden and in cooperation with Dresden's Coordination Center for Clinical Studies by the Clinical Studies Department of the Medical Clinic and Polyclinic I at Dresden University Medicine and implemented at various centers in Germany as part of the Study Alliance Leukemia (SAL) academic study group. With over 50 participating centers in Germany and Austria, SAL is one of the two large German AML study groups and is coordinated by its Dresden-based study center. The company AbbVie supported the project financially and provided the medication used in the study. Partners included the hematology departments of the university hospitals in Münster, Kiel, Essen, Frankfurt am Main, Würzburg, Augsburg, Marburg, Nuremberg, the Robert Bosch Clinic in Stuttgart, the Chemnitz Clinic and the Red Cross Clinic in Munich.
Publication:
"Venetoclax plus high-dose cytarabine and mitoxantrone as salvage treatment for relapsed or refractory acute myeloid leukaemia (RELAX): a multicentre, single-arm, phase 1/2 trial", Ruhnke, Leo et al., The Lancet Haematology, Volume 13, Issue 3, e157 - e168 DOI: https://doi.org/10.1016/S2352-3026(25)00358-8
Background:
Dresden University Medicine is one of the leading international institutions in the field of hematologic diseases. It was only last year that a novel therapeutic approach for acute promyelocytic leukemia (APL) , a rare subtype of acute myeloid leukemia, was successfully established in Dresden.
