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RECRUITING
NCT07771803
EARLY_PHASE1

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

Sponsor: Roger Strair

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-06-30

Completion Date

2026-12-30

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

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.

Locations (1)

MDA at Cooper University Health Care

Camden, New Jersey, United States