Recruiting
Early Phase 1

Annona Muricata

Sponsor:

Roger Strair

Code:

NCT07771803

Conditions

AML (Acute Myeloid Leukemia)

Multiple Myeloma Refractory

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soursop tea

Study Details

Brief 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).

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

AML (Acute Myeloid Leukemia)

Multiple Myeloma Refractory

Study ID

NCT07771803

Start date

Jun 30, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML)

experimental: 10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM)

Interventions

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 measure

  • Dependent Variables or Outcome Measures [ Time Frame: From enrollment until end of treatment- 21 days ]

Central Contacts and Locations

Central contacts

John Riehman-Murphy, RN

215-756-2772riehmanmurphy-john1@cooperhealth.edu

Roseann Freitag

856-325-6733freitag-roseann@cooperhealth.edu

Locations

MDA at Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 18103

More Information

Sponsor

Roger Strair

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • relapsed/refractory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roger Strair on 2026-08-18.