For more information, please contact Cancer Clinical Trials Office (CCTO), 65. Stanford is currently not accepting patients for this trial. The parent protocol, or 3 years of post-treatment from last dose, whichever occurs later. Study when all participants fulfill at least 5 years from the first dose of luspatercept in The rollover study will be terminated, and relevant participants will discontinue from the (safety or LTPTFU) will continue from the same equivalent point in this rollover study. Participants transitioning from a parent luspatercept study in post-treatment follow-up New anticancer orĭisease related therapies should be collected at the same time schedule
Monitored for progression to AML or any malignancies/pre-malignancies. Termination, or until a subject is lost to follow-up. Participants will be followed for overall survival every 6 months for at least 5 yearsįrom first dose of luspatercept in the parent protocol, or 3 years of post-treatmentįrom last dose, whichever occurs later, or until death, withdrawal of consent, study Long-term Post-treatment Follow-up (LTPTFU) Phase Last dose of luspatercept, for the assessment of safety-related parameters and adverse During the Safety Follow up, the participants will be followed for 42 days after the This does not apply to participants that are in long-term follow-up Luspatercept in this study will be the same as the last dose and schedule in the parent Treatment Phase: For participants in luspatercept treatment the dose and schedule of Transition Phase is defined as one Enrollment visit Participants will enter transition phase and depending on their background willĮnter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) The study design is divided into the Transition Phase, Treatment Phase and Follow-up Rollover study until the follow-up commitments are met The parent protocol will continue into long-term post-treatment follow-up in the Participants in the follow-up phase previously treated with luspatercept or placebo in To the rollover study, who tolerate the protocol-prescribed regimen in the parent trialĪnd, in the opinion of the investigator, may derive clinical benefit from continuing Participants receiving luspatercept on a parent protocol at the time of their transition Luspatercept, to the following participants: His current investigations include evaluation of ex vivo drug sensitivity methods for identifying potentially useful and often novel therapeutic drugs for patients with myeloid neoplasms refractory to standard therapies.Ī Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of His prior laboratory investigations included biologic studies of MDS-related myeloid progenitor cell proliferation as well as mutational and transcriptomic evaluation of gene expression profiles contributing to prognosis in MDS. He is Chair of the NCCN Practice Guidelines Panel for MDS. He is Coordinator of the International Working Group for Prognosis in MDS (IWG-PM) which generated the revised MDS classification system (the IPSS-R) and the impact of molecular mutations for a risk-based prognostic system, the IPSS-Molecular (IPSS-M). His clinical research involves design and coordination of clinical trials using experimental drugs with biologic focus for both lower and higher risk MDS patients not responding to standard therapies.
Stanford Woods Institute for the Environment.Stanford Institute for Economic Policy Research (SIEPR).Institute for Stem Cell Biology and Regenerative Medicine.Institute for Human-Centered Artificial Intelligence (HAI).Institute for Computational and Mathematical Engineering (ICME).Freeman Spogli Institute for International Studies.School of Earth, Energy and Environmental Sciences.
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