Peptide Radionuclide Therapy for Myelodysplastic Syndrome Risks
(MDS & PRRT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the risks of developing certain blood disorders, such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), in patients receiving peptide radionuclide therapy (PRRT). Researchers seek to determine if some patients are more likely to develop these conditions after PRRT and the reasons behind it. The trial includes individuals about to start PRRT, those who received it in the past few years, and those who developed MDS or AML following PRRT. Individuals scheduled for PRRT soon or who had it recently and are willing to undergo genetic tests might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding the long-term effects of PRRT and potentially improve future patient outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this observational study is safe?
Research shows that Peptide Receptor Radionuclide Therapy (PRRT) can cause serious side effects. Studies have found a potential long-term risk of developing therapy-related myeloid neoplasms (t-MN), severe blood disorders that are difficult to treat. These conditions often have a poor outlook due to their aggressive nature and resistance to standard treatments.
However, not everyone experiences these side effects, and they may only appear after a long time. Other research indicates that patients receiving PRRT can live without disease progression for about two years on average and can live for about four years on average, suggesting some positive outcomes from the treatment.
Considering these risks and benefits is important when evaluating PRRT. Discuss any concerns with a healthcare provider to understand how they might apply.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's diving into the risks of developing myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) in patients undergoing peptide radionuclide therapy (PRRT) for neuroendocrine tumors (NETs). Unlike standard treatments that may not consider long-term risks, this trial aims to understand how PRRT might lead to clonal hematopoiesis, which can be a precursor to blood disorders like MDS or AML. By closely monitoring patients before, during, and after PRRT, researchers hope to pinpoint any early signs of these conditions, potentially leading to better screening and prevention strategies for patients receiving this type of therapy.
What evidence suggests that this trial's treatments could be effective for MDS and AML?
Research has shown that Peptide Receptor Radionuclide Therapy (PRRT) effectively treats neuroendocrine tumors (NETs), particularly those that cannot be surgically removed or have metastasized. PRRT delivers high doses of radiation directly to tumors, destroying or slowing their growth and often reducing symptoms. However, studies have identified a risk of developing blood disorders, such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), in some patients after treatment. Specifically, out of 1,631 patients who received PRRT, 30 developed these disorders, with 23 cases being MDS. This trial will include different groups of patients: those planned for PRRT, those who have previously received PRRT, and those diagnosed with therapy-related myeloid neoplasms (t-MN), such as MDS or AML, after PRRT. While PRRT is generally effective for NETs, understanding and managing these risks is crucial for patient safety.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-PRRT Assessment
Patients planned for PRRT undergo genetic panel testing to identify predisposition to MDS/AML
Post-PRRT Monitoring
Annual genetic panel testing to detect genetic mutations and assess variant allele frequencies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Peptide receptor radionuclide therapy (PRRT)
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Patients who have received PRRT within the last 4 years. There are no baseline levels available for cohort A patients. Sample size: 20.
Patients who have t-MN (MDS or AML). Sample size: 5.
Patients who are scheduled to start PRRT in the next 3 months. Pre-PRRT clonal expansion status will only be available form this cohort. These patients will provide a comprehensive record of development of CH from exposure to PRRT. Sample size: 20.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Citations
Therapy-related myeloid neoplasm after peptide receptor ...
Out of 1631 patients treated with PRRT, 30 patients developed t-MN comprising myelodysplastic syndrome (MDS) in 23 patients (77%) and acute myeloid leukemia ( ...
Therapy-related hematological malignancies after peptide ...
High risk of myelodysplastic syndrome and acute myeloid leukemia after 177Lu‐octreotate PRRT in NET patients heavily pretreated with alkylating ...
Evaluating Myelodysplastic Syndrome Risks in NET ...
PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects. While PRRT is generally well ...
Myeloid neoplasms after chemotherapy and PRRT
It is now widely accepted that peptide receptor radionuclide therapy (PRRT) is an effective treatment for inoperable or metastatic neuroendocrine tumors (NETs).
Characteristics and outcomes of therapy-related myeloid ...
The diagnosis of t-MN after PRRT/PRCRT is an infrequent but serious complication with poor overall survival. Most patients present with thrombocytopenia.
Therapy-related myeloid neoplasms in 177Lu-DOTATATE ...
This review synthesizes data on PRRT-related hematologic toxicities, including findings from pivotal studies and real-world evidence.
Incidence and characteristics of therapy-related myeloid ...
Therapy-related myeloid neoplasm (t-MN) has been reported as a potential long-term and frequently lethal adverse event after PRRT . Oncologists ...
Assessment of Therapy-Related Myeloid Neoplasms in ...
Therapy-related myeloid neoplasm (t-MN) has been reported as a potential long-term and frequently lethal adverse event after PRRT. However, the ...
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aacrjournals.org
aacrjournals.org/bloodcancerdiscov/article/5/6/400/749228/Therapy-Related-Myeloid-Neoplasms-ComplexTherapy-Related Myeloid Neoplasms: Complex Interactions ...
The prognosis of t-MN is universally dismal due to its aggressive nature and treatment refractoriness to conventional therapies, including stem ...
Peptide Receptor Radionuclide Therapy of ...
In relation to survival analysis, patients treated with PRRT showed a median of 2-years for progression free survival (PFS) and 4 years of overall survival (OS) ...
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