Exclusive: St. Jude Children’s suspends enrollment in cancer trials over toxicity concerns

st judesSt. Jude Children’s Research Hospital in Memphis has temporarily halted enrollment in six bone marrow transplant trials due to concerns over how side effects were being identified in medical records, Retraction Watch has learned.

According to a source familiar with the trials, five of the six being suspended were all enrolling children with blood cancers who lacked a matching donor. During the trials, doctors took bone marrow from a parent — not a perfect match — and manipulated the cells before transplant to make them more capable of killing cancer, and less likely to be rejected.

Four trials, a few of which were scheduled to enroll more than 100 children, are being led by Brandon Triplett. Two are led by Mari Dallas, according to the source. Genzyme and the U.S. National Cancer Institute are listed as collaborators. Both Dallas and Triplett work under bone marrow transplant department chair Wing Leung.

We reached out to Scientific and Comprehensive Cancer Center Director Richard Gilbertson, who referred us to PR firm Rubenstein Public Relations. They sent us the following statement:

As part of an administrative review of the records associated with two bone marrow transplantation protocols, a question arose regarding the accuracy of coding of treatment-related toxicity. Although the overall outcomes of patients on these protocols has been excellent, out of an abundance of caution, the institution has temporarily paused enrollment of new patients on these two protocols and four additional Bone Marrow Transplantation (BMT) protocols. A detailed audit of the research records of all of the patients enrolled on these protocols is already underway. The pause in new patient enrollment to these protocols will not affect the ongoing care for the patients currently being treated through these protocols.

Prior to the announcement, researchers at St. Jude published several publications stating that, so far, no patients in the trials had developed graft versus host disease (GVHD), a common treatment-related toxicity in bone marrow transplants. According to the NIH, between 30 and 80% of patients will develop complications from GVHD, which range from diarrhea to liver failure, and can be fatal.

We asked the St. Jude PR rep whether GVHD was the toxicity in question, and if there would be any retractions. They responded via email:

There is no evidence at this time that it will affect any publications; we can’t comment on treatment toxicity specifics until the review is complete.

We’ve also reached out to Leung, Dallas, and Triplett, and will update if we hear back.

One thought on “Exclusive: St. Jude Children’s suspends enrollment in cancer trials over toxicity concerns”

  1. I can fully understand the risks, but isn’t it sad when directors and scientists cannot speak for themselves and have to rely on PR firms and lawyers to express what they want to say? In some ways, one could claim that 600 years ago, there may have been more freedom of speech by scientists than today, but possibly with worse-off risks.

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