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RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether soursop leaf tea is safe and can lower the number of cancer cells. It is for people with acute myeloid leukemia (AML) or multiple myeloma (MM) whose cancer came back or did not respond to treatment and who have no standard treatment options left. People will drink the tea more often over 21 days.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have AML or MM that came back or did not respond to treatment, have used all available treatments, and are not taking cancer treatment now.
  • For AML: Have measurable leukemia cells in the blood, or agree to bone marrow tests before and after treatment.
  • For MM: Have a measurable M protein on a blood test, or an abnormal free light chain ratio above 10. These tests measure proteins linked to myeloma.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG activity score 0–2).
  • Meet blood test limits: liver enzymes ALT and AST below 3 times the upper normal limit; bilirubin below 2.5 mg/dL; and kidney filtering rate (estimated GFR) above 40 mL/min.
  • Have no active or uncontrolled infections.
  • Have a negative pregnancy test if you could become pregnant.
  • Have no long-term nerve or brain disorders, such as nerve damage above grade 2, Parkinson’s disease, or Alzheimer’s disease. Other nerve or brain diseases must be discussed with the lead study doctor.

Who can't join

  • Cannot understand the study steps or consent form.
  • Are pregnant or breastfeeding.
  • Cannot or will not use effective birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NJ