The Myelodysplasia Transplantation-Associated Outcomes (MDS-TAO) Study

NCT02390414 | Completed Results DMC

• 1 other identifier: 11-056
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this observational study is to compare overall survival in older adults with myelodysplastic syndromes (MDS) who receive reduced intensity conditioning hematopoietic stem cell transplant (RIC HSCT) versus those who do not receive HSCT.

Conditions

Myelodysplastic Syndromes (MDS)

Keywords

Myelodysplastic syndromes (MDS)

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  To prospectively compare the overall survival of patients in the HSCT group to that of patients in the non-HSCT group.

  3 Years

Study Arms (2)

Gets HSCT

Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT and actually undergo HSCT.

No HSCT

Patients with higher-risk myelodysplastic syndrome (MDS) aged 60-75 who are fit for HSCT but do not undergo HSCT.

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be 60 to 75 years old with a diagnosis of MDS or related disorder (eg, MDS/MPD or CMML) who have disease that is advanced enough to warrant RIC HSCT (defined by high-risk cytogenetics OR int-2 or high-risk on IPSS OR transfusion dependence as defined by WPSS) and who are physically fit enough to undergo RIC HSCT as assessed by pre-determined measures of organ function. Patients whose baseline donor status is known will be excluded; however, knowledge of HLA status is allowed as long as a donor search has not been performed.

You may qualify if:

• Histologically-confirmed diagnosis of:
• Primary or secondary MDS using the World Health Organization (WHO) 2008 classification:
• Refractory cytopenia with unilineage dysplasia
• Refractory Anemia (RA)
• Refractory Neutropenia (RN)
• Refractory Thrombocytopenia (RT)
• Refractory Anemia with Ring Sideroblasts (RARS)
• Refractory Cytopenia with Multilineage Dysplasia (RCMD)
• Refractory Anemia with Excess Blasts-1 (RAEB-1)
• Refractory Anemia with Excess Blasts-2 (RAEB-2)
• MDS with isolated del (5q)
• MDS-Unclassified (MDS-U)
• Another of the following related disorders:
• Chronic Myelomonocytic leukemia (CMML)
• Myelodysplastic/myeloproliferative neoplasm, unclassifiable (MDS/MPD-U)

You may not qualify if:

• Known baseline conversion to AML (eg, ≥ 20% peripheral or marrow blasts).
• Knowledge of potential donor status at study entry. Of note, knowledge of HLA status WITHOUT a related or unrelated search is allowed.
• History of prior malignancy within the past year, except for adequately-treated carcinoma in situ of uterine cervix, basal cell or squamous cell skin cancer.
• Any severe concurrent disease, infection, or comorbidity that, in the judgment of the principal investigator, would make the patient inappropriate for HSCT at the time of study entry.
• Psychiatric disorders including dementia that would preclude obtaining informed consent or the ability to participate in an ongoing research study.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Fit older adults with advanced myelodysplastic syndromes: who is most likely to benefit from transplant?

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Gregory A. Abel
• Organization: Dana-Farber Cancer Institute

gaabel@partners.org

6176322304

Study Officials

• Gregory A Abel, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 17, 2015
• Study Start: May 1, 2011
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 3, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-03

Locations

US (3)