NCT07771803 · Roger Strair
A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
(Soursop)
What this study is about
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).
View original scientific description
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.
Interventions
BIOLOGICAL
Soursop tea
The study is designed to test soursop tea therapy for 21 days, seven at each of 3 dose levels (1, 2 and 3 eight-ounce cups of soursop tea/d with each tea bag containing 1.5g of Shavuot leaves). Some patients may be on study for longer periods due to delays for toxicity observation. Only one delay will be allowed per patient. The patients will be assessed for leukemic or myeloma burden at the end of therapy. All patients will be monitored until resolution of tea-associated toxicities. All patients continuing soursop tea after the 21 days of treatment will continue to be followed for response and toxicity. If a specific intervention-associated CTCAE grade 2 or greater irreversible toxicity occurs in more than one person, the study will be stopped.
Primary outcome measures
Dependent Variables or Outcome Measures
Time frame: From enrollment until end of treatment- 21 days
Reduction in AML cell percentage in blood or bone marrow e.g. (a \>50% reduction in circulating leukemia cells) for the AML cohort. A 50 percent reduction in monoclonal protein or serum free light chains in the multiple myeloma cohort. Tea-associated toxicity will be graded by CTCAE v6 standards.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Camden, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations