Clinical trial · Interventional
A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML (Acute Myeloid Leukemia) | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Multiple Myeloma Refractory | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Soursop tea | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML)
- interventionNames
- Biological: Soursop tea
- type
- EXPERIMENTAL
- label
- 10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM)
- interventionNames
- Biological: Soursop tea
Primary outcomes (1)
- measure
- Dependent Variables or Outcome Measures
- timeFrame
- From enrollment until end of treatment- 21 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available