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A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)

RecruitingEARLY Phase 1Ages 18 Years - anyAllRoger Strair
NCT07771803 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Purpose/Specific Aims The study will determine if there is a reduction in malignant cell burden when patients with relapsed and/or refractory acute myeloid leukemia (AML) or multiple myeloma (MM) consume tea made from the dried leaves of Annona muricata (Soursop). The study goal is to determine the safety and anti-neoplastic efficacy of Annona muricata tea when taken in escalating frequency over a period of 21 days by patients with relapsed/refractory AML or MM for whom there are no standard therapeutic options.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with relapsed or refractory AML or MM not on any anti-neoplastic therapy who have exhausted all therapies and have no available therapy. * For AML: Quantifiable leukemia cells in blood (patients without circulating AML blasts may participate if they agree to baseline and post-treatment bone marrow testing) * For MM: Quantifiable M component (SPEP) or serum free light chain abnormality (ratio greater than 10) * ECOG PS 0,1, or 2 * ALT, AST less than 3 times ULN * Bilirubin (total) \< 2.5 mg/dL * Renal function - estimated GFR \> 40 ml/min * No uncontrolled/active infections * Negative pregnancy test if of childbearing potential * No chronic neurologic disorders (peripheral neuropathy \> grade 2; Parkinson's disease; Alzheimer's disease; other neurologic diseases will be discussed with the PI) Exclusion Criteria: * Inability to understand the study procedures * Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception
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What it tests

  • Soursop tea
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Where

1 site
MDA at Cooper University Health Care
Camden, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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