Myelodysplastic SyndromePhase 2NCT01099917
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?
A Phase 2 study testing Maitake in people with Myelodysplastic Syndrome, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Maitake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age ≥55 years
Who cannot join
- IPSS (High risk)
- History of AML
- History of Stem Cell transplant
- Known history of HIV+
- Allergy to mushrooms
- Bone Marrow blasts >10%
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- HEALTHY CONTROL ELIGIBILTY 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).
Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Maitake
- Keywords
- MDS, Maitake, mushroom, 09-094
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaitakeDrug
Patients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol.
Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test.
| Study group | Role | What they receive |
|---|---|---|
| Maitake | Experimental | This is a phase II trial examining hematopoietic response in MDS patients. Receives: Drug: Maitake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neutrophil Counts
The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients
Measured: baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- YUKIGUNI COMPANY, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Kathleen Wesa, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099917
- Sponsor's protocol ID
- 09-094
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2010
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
- ClinicalTrials.gov ID
- NCT01099917
- Acronym / sponsor ID
- 09-094
- Conditions
- Myelodysplastic Syndrome
- Keywords
- MDS, Maitake, mushroom, 09-094
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- YUKIGUNI COMPANY, Weill Medical College of Cornell University
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Posted 19 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).
Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maitake | Experimental | Drug: MaitakeThis is a phase II trial examining hematopoietic response in MDS patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Age ≥55 years
Key exclusion criteria (10 listed)
- IPSS (High risk)
- History of AML
- History of Stem Cell transplant
- Known history of HIV+
- Allergy to mushrooms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaitakePatients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol. Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test. | Drug | Maitake |
Primary outcome
Changes in Neutrophil Counts
Time frame: baseline and week 12
The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for Myelodysplastic Syndrome
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Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Wesa, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maitake in people with Myelodysplastic Syndrome, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neutrophil Counts (time frame: baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.