Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN)

NCT03140280 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO28985
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, single-group pilot study to evaluate efficacy and methylation. This study's overarching aim is to evaluate the systemic effects of black raspberries in patients with myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm. Twenty-one patients with MDS will be treated with 25 gm (2x/day) of BRB powder taken orally.

Conditions

Myelodysplastic Syndromes

Keywords

Black raspberries; MDS; Myelodysplastic Syndromes; hypomethylating effects; chemopreventive agent; BRB; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Grade 3 or Higher Serious Adverse Events.

  Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; patients will be evaluated every four weeks for toxicity.

  Up to 52 weeks

Secondary Outcomes (1)

• The Number of Subjects Showing a Response.

  Up to 52 Weeks

Study Arms (1)

Dietary Intervention

EXPERIMENTAL

Freeze-dried black raspberry powder administration.

Drug: Freeze-Dried Black Raspberry Powder

Interventions

Freeze-Dried Black Raspberry Powder DRUG

25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.

Dietary Intervention

Eligibility Criteria

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

You may qualify if:

• Patients must have a confirmed diagnosis of myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) proven by bone marrow biopsy/aspirate.
• Patients with cytopenias (blood cell counts lower than the institutional lower limit of normal within the eight weeks prior to the study) who are receiving or received:
• red blood cell transfusions
• observation
• platelet transfusions
• erythropoietin
• granulocyte colony-stimulating factors
• granulocyte-macrophage colony-stimulating factors
• hydrea
• Age \>18 years.
• Predicted life expectancy of at least 12 weeks.
• Patients should be expected to stay on the same therapy for the period of the study.
• Patients who do not have an indication for and/or are unable to tolerate a hypomethylating agent are eligible for the study.
• Reproductive requirements:
• Female patients must meet one of the following:

You may not qualify if:

• Previously received hypomethylating agents.
• Allergy to black raspberries.
• Inability to swallow oral medication.
• Inability or unwillingness to comply with the BRB administration requirements.
• Uncontrolled intercurrent illness, including, but not limited to, symptomatic congestive heart failure, or psychiatric illness/social situations, that, in the treating investigator's discretion, would limit compliance with study requirements.
• Active infection not well controlled by antibacterial or antiviral therapy.
• Pregnant or lactating women.
• Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.

Sponsors & Collaborators

• Ehab L Atallah: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Ehab Atallah, MD
• Organization: Medical College of Wisconsin

eatallah@mcw.edu

414-805-4600

Study Officials

• Ehab Atallah, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Medicine, Division of Hematology/Oncology

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: May 4, 2017
• Study Start: June 5, 2017
• Primary Completion: June 1, 2019
• Study Completion: May 28, 2021
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)