AML (Acute Myeloid Leukemia)Early Phase 1SoursopNCT07771803
A Pilot Study of Soursop Tea in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM)
A Early Phase 1 study testing Soursop tea in people with AML (Acute Myeloid Leukemia) and Multiple Myeloma Refractory, run by Roger Strair at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML (Acute Myeloid Leukemia), Multiple Myeloma Refractory
- What is being tested?
- Soursop tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- Inability to understand the study procedures
- Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MDA at Cooper University Health Care
Camden, New Jersey, 18103
About this study
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.
Read the detailed description
Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM) are aggressive blood cancers. The median age of patients diagnosed with AML is between 65 and 70 years old and, despite recent advances in the management, most studies demonstrate less than 25% 5-year survival of patients over age 60. Likewise, although there have been extraordinary breakthroughs in the care of patients with MM, most patients with MM currently ultimately die of their disease.
Annona muricata is a plant that is native to Central and South America and found also in parts of the Caribbean, Europe, Asia and Africa. It is known by various names throughout the world (soursop, gravioloa, guanabana, paw paw, nangka balanda, and others). Seeds, fruit and leaves from the plant have all been used to treat a variety of diseases and ailments. The leaves are acuminate with a dark green upper surface and extracts include a variety of pharmacologically active classes of molecules (acetogenins, alkaloids, flavonoids) and a variety of their secondary products.
This pilot study is designed to determine if there is any signal of anti-neoplastic activity when patients with refractory/relapsed AML or MM with no standard therapeutic options available consume soursop tea.
- Being tested
- Soursop tea
- Keywords
- relapsed/refractory
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soursop teaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML) | Experimental | Not described Receives: Biological: Soursop tea |
| 10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM) | Experimental | Not described Receives: Biological: Soursop tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependent Variables or Outcome Measures
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.
Measured: From enrollment until end of treatment- 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start30 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roger Strair
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roger Strair, The Cooper Health System
- Investigators
- Roger Strair, MD, Principal investigator, Cooper University Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771803
- Sponsor's protocol ID
- IRB 25-050
- Other IDs
- 171498
- Acronym
- Soursop
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No