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

NCT07771803 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: IRB 25-050171498
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

relapsed/refractory

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until end of treatment- 21 days

Other Outcomes (1)

• Dependent Variables or Outcome Measures

  From enrollment until end of treatment- 21 days

Study Arms (2)

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

EXPERIMENTAL

Biological: Soursop tea

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

EXPERIMENTAL

Biological: Soursop tea

Interventions

Soursop tea BIOLOGICAL

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.

10 patients will be enrolled with the diagnosis of relapsed/refractory acute myeloid leukemia (AML); 10 patients will be enrolled with the diagnosis of relapsed/refractory multiple myeloma (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Inability to understand the study procedures
• Inability to understand the consent form --Pregnancy, breastfeeding, or inability or unwillingness to use effective contraception

Sponsors & Collaborators

• Roger Strair: lead

Study Sites (1)

MDA at Cooper University Health Care

Camden, New Jersey, 18103, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roger Strair, MD

  Cooper University Health Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Riehman-Murphy, RN

CONTACT

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

Roseann Freitag

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 18, 2026
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)