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

Part of paid clinical trials in Camden, New Jersey.

Sponsor
Roger Strair
Study ID
NCT07771803
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • AML (Acute Myeloid Leukemia)
  • Multiple Myeloma Refractory

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

First listed
Aug 18, 2026
Start date
Jun 30, 2025
Status verified
Aug 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MDA at Cooper University Health CareCamdenNew Jersey18103-

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MDA at Cooper University Health Care· Camden, NJ

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