Next year, we expect to launch a new master protocol – MyeloMATCH, an umbrella trial that will test treatments for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

Get ready. This trial is truly trailblazing.

Dr. Harry Erba, our long-time leukemia committee chair, has taken a lot of lessons from past SWOG and National Cancer Institute master protocols, like Lung-MAP and NCI-MATCH, and is ready to put them into practice. The trial is truly collaborative, planned intensively with the NCI and our partners in the National Clinical Trials Network and to be run with scientific input from all the groups involved. Most notably, MyeloMATCH will feature the first universal identifiers used in any NCTN trial. These identifiers anonymize patient data, protecting the privacy of trial participants and allowing them to be easily tracked as they move through different MyeloMATCH sub-studies. Universal identifiers are a holy grail for clinical trial conduct, and we will make it happen for the first time in the NCI.

I couldn’t be more impressed by work already done by Dr. Erba and his MyeloMATCH co-chair, Dr. Mark Litzow of Mayo Clinic and ECOG-ACRIN. The idea to run a master protocol for leukemia has been around for years, but in the last two years, they’ve really built the trial team and infrastructure, with strong support from Dr. Rich Little at NCI. The need is great. While bone marrow transplants have saved the lives of tens of thousands of people with AML, relapse is common. And of course there are many patients – especially the frail elderly – who can’t handle the physical rigors of a transplant and don’t get the benefits of this potentially curative option. Given the median age of AML patients at diagnosis is 68 years, and the 5-year survival of AML patients over the age of 65 years at diagnosis is only 5 percent, we need to accelerate the speed with which we identify new, effective, and tolerable treatment options for these patients based on our deeper understanding of the biology of this disease.

Under MyeloMATCH, the idea is to enroll participants at the time of initial AML or MDS diagnosis and get them on a long-term treatment track using currently available therapies as well as investigational agents. These patients are a heterogenous group – healthy older adults, sick older adults, and healthy young adults with AML or MDS. Everyone will have their blood genetically screened using next-generation sequencing, and get assigned to an initial sub-study. If they relapse, or if they experience significant toxicities, they can move to another sub-study to receive a different treatment. The goal: Quickly test drugs for efficacy.

A key asset of MyeloMATCH is collaboration and shared decision-making. SWOG will oversee the screening protocol for the trial, but there are many groups involved – SWOG, ECOG-ACRIN, the Alliance, Canadian Cancer Trials Group, and Children’s Oncology Group. Each group, as well as representatives of CTEP and the Investigational Drug Branch at NCI, has a seat on the senior scientific council, which will provide overall scientific direction for the initiative. The most promising targets, the best-in-class agents, and the best-in-class laboratory assays will be identified through the agents and genes committee and the laboratory committee. These two committees are also composed of investigators from all of the NCTN leukemia committees and the NCI. Drug companies are brought in early for discussions, and NCI will develop cooperative research and development agreements (CRADAs) with all pharma partners. Several are already on board, and many others have asked to meet with the MyeloMATCH senior scientific council to discuss collaborations. We hope this process allows us to identify common ground with our pharma partners and CTEP early in protocol development.

SWOG will complete a patient’s initial genetic screening, but all other tests will be run through NCI’s MDNet for efficiency. Samples will be stored at the SWOG Biorepository at Nationwide. We plan to have IDE for these assays so that our trials can potentially lead to FDA approval of novel agents based on identified subsets of patients with myeloid neoplasms. And CRADAs smooth the way by managing intellectual property issues in advance.

“We’ve worked hard to be inclusive and to streamline the process,” Erba says. “We’ll be able to quickly assess the toxicity and effectiveness of different agents, and if they’re promising, then our industry partners or the NCTN can move on to a phase III trial. MyeloMATCH is all about signal finding. We hope that MyeloMATCH will help us get best-in-class targeted cancer treatments to the American people as fast as we possibly can. MyeloMATCH will allow us to test novel-novel combinations with best-in-class agents even if different pharma partners are involved.”

The master screening protocol is still under construction, but we expect some of the first MyeloMATCH sub-studies will hit executive review teams across the NCTN later this year. The trial is scheduled to launch mid-year 2021.

I am quite glad the chairs of the NCTN leukemia committees, as well as the NCI’s Dr. Little, are working together to make this happen. It looks like it could be a very real boon for our patients.

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