Innovative Therapy Boosts Remission Rates in Aggressive Leukemia, RELAX Study Shows

A new Germany-wide study led by Dresden University Medicine demonstrates that combining intensive chemotherapy with the drug venetoclax significantly improves treatment outcomes for patients with aggressive acute myeloid leukemia (AML). The results of the RELAX study, published in The Lancet Haematology, show a 75 percent remission rate compared to a historical rate of 40 percent.

Understanding Acute Myeloid Leukemia and Treatment Challenges

Acute myeloid leukemia is a rapidly progressing form of blood cancer. While chemotherapy can often control the disease, it frequently returns. A potential cure often relies on a stem cell transplant, but this is only possible if the leukemia can be sufficiently suppressed beforehand.

“If AML no longer responds 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 the Technical University of Dresden (TUD). “By this time, still, it can be difficult to control swift-growing AML with chemotherapy.”

The RELAX Study: A Novel Combination Approach

The RELAX study – a phase 1/2 trial – investigated whether combining standard therapy with cytarabine and mitoxantrone (HAM) with the BCL2 inhibitor venetoclax could improve treatment success. Researchers first tested the tolerability of the combination and then its effectiveness.

“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,” reports Dr. Leo Ruhnke, senior hematologist and first author of the publication. “The majority of those treated were able to successfully receive a stem cell transplant.”

Promising Results for Persistent AML Forms

The therapy similarly showed effectiveness against 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 of the Medical Clinic I and member of the Executive Board of the National Center for Tumor Diseases (NCT/UCC) Dresden and Professor at the Medical Faculty.

“The RELAX study shows how academic clinical research in cooperation with industrial partners can significantly improve the treatment of cancer,” Bornhäuser added.

Expanding Access and Future Outlook

The treatment is already being used to treat patients. “Together with colleagues from Münster, we are currently evaluating the results of over 150 additional AML sufferers who were treated according to the HAM-Ven scheme after the end of study recruitment in Germany. The initial data are promising,” says Röllig.

Researchers believe the new therapy has a strong potential to become the new standard of treatment for relapsed AML and to improve the chances of recovery by facilitating stem cell transplants.

“The RELAX study illustrates how scientific excellence and clinical expertise work together in Dresden to develop innovative therapies,” explains Prof. Esther Troost, Dean of the TUD Medical Faculty. “Only through such studies can we guarantee the safety and effectiveness of new treatment approaches.”

“The results of the RELAX study represent great progress because they provide us with new, effective options for giving patients better starting conditions on the way to a life-saving stem cell transplant,” says Prof. Uwe Platzbecker, Medical Director of the University Hospital Dresden.

About the Study

The RELAX study was sponsored by the Medical Faculty of the TU Dresden and implemented multicenter in Germany as part of the academic study group Study Alliance Leukemia (SAL). AbbVie provided financial support and the study medication.

Participating centers included 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.

Sources:

• Eurekalert: RELAX study from Dresden
• ScienMag: Innovative Combination Therapy Demonstrates Promising Results in Aggressive Leukemia
• The Lancet Haematology: Venetoclax plus high-dose cytarabine and mitoxantrone as salvage treatment