An Early Phase 1 interventional study of Soursop tea in AML (Acute Myeloid Leukemia) and Multiple Myeloma Refractory, sponsored by Roger Strair. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Roger Strair · Early Phase 1, Interventional, and Treatment
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.
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →This is the only study on the registry with Roger Strair as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Soursop tea
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.
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.
Time frame: From enrollment until end of treatment- 21 days
Dependent Variables or Outcome Measures
The assessments chosen are greatly simplified because of the pilot nature of the study. 1. AML response will be measured as a percentage change in AML blast count in blood and/or bone marrow at the completion of therapy. 2. Multiple myeloma response will be determined by percentage change in serum M component (when assessable) and/or involved serum free light chain (when assessable).
Time frame: From enrollment until end of treatment- 21 days
Plan to share: No
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