Soursop tea in relapsed/refractory AML or multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase pilot evaluates the safety and potential anti-cancer effects of Annona muricata (soursop) leaf tea taken in escalating frequency over 21 days in patients with relapsed or refractory AML or MM who have no standard options left. Participants will receive soursop tea as the investigational intervention and will be monitored for adverse effects and changes in disease markers. The study includes adults with adequate organ function and no active infections, and it aims to observe signals of anti-neoplastic activity rather than to establish efficacy. Background information notes the aggressive nature of AML and MM and the traditional use of soursop leaves in various cultures.

Why it matters

Who can join: the full rules

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

Where it's running

• MDA at Cooper University Health Care
  Camden, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Roger Strair, MD — Cooper University Health Care
• Study coordinator: John Riehman-Murphy, RN
• Email: riehmanmurphy-john1@cooperhealth.edu
• Phone: 215-756-2772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.