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Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome

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Trial Information

Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial


Inclusion Criteria:



- MSKCC patients age 18 or older able to sign informed consent

- Absolute Neutrophil count >0.5 K/mcL

- Diagnosis of MDS by bone marrow biopsy

- Patient not a candidate for aggressive standard treatment

Exclusion Criteria:

- IPSS (High risk)

- History of AML

- History of Stem Cell transplant

- Known history of HIV+

- Allergy to mushrooms

- Bone Marrow blasts >10%

HEALTHY CONTROL ELIGIBILTY CRITERIA

Inclusion Criteria

- Age ≥55 years

Exclusion Criteria

- Currently taking corticosteroids or other immunosuppressants

- Known history of HIV+

- Current or previous malignancy or hematology disorder except adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumors curatively treated with no evidence of disease for > 3 years

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To describe changes in neutrophil counts and neutrophil function in MDS patients following administration of Maitake mushroom extract.

Outcome Time Frame:

weeks 1, 3, 7, 9 and 12.

Safety Issue:

No

Principal Investigator

Kathleen Wesa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

09-094

NCT ID:

NCT01099917

Start Date:

April 2010

Completion Date:

April 2013

Related Keywords:

  • Myelodysplastic Syndrome
  • MDS
  • Maitake
  • mushroom
  • 09-094
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021