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

Description

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.

Study Start Date

April 2011

Estimated Completion Date

April 2021

Interventions

No interventions cited

Specialties

  • Oncology: Leukemia/Lymphoma
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • ,Preleukemia
  • Myelodysplastic

Study ID

Dana-Farber Cancer Institute -- 11-056

Status

Recruiting

Trial ID

NCT02390414

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

290

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • 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)
  • Age 60 to 75 years
  • Any of the following (high-risk characteristics):
  • Intermediate-2 or High-Risk on International Prognostic Scoring System (IPSS)
  • Secondary MDS (any karyotype)
  • Documented non-IPSS intermediate
  • or poor-prognosis karyotype including:
  • +8
  • t(11q23)
  • Rea 3q
  • +19
  • 3 or greater abnormalities
  • del(7q)
  • -5
  • t(5q)
  • Documented significant cytopenia for at least four months prior to enrollment, defined by the following criteria:
  • Red Blood Cell (RBC) Transfusion Dependence: four or more units of RBC transfusions within an eight-week period for symptomatic anemia with hemoglobin of ? 9.0 g/dL
  • OR
  • Severe Anemia: average of two or more hemoglobin values ? 8 g/dL within an eight-week period not influenced by RBC transfusions (i.e., must be seven days post transfusion)
  • OR
  • Severe Thrombocytopenia: average of two or more platelet counts ? 50 × 109/L within an eight-week period not influenced by platelet transfusions (i.e., must be at least three days post
  • transfusion) or a clinically significant hemorrhage requiring platelet transfusions within the prior four months
  • OR
  • Severe Neutropenia: average of two or more absolute neutrophil counts (ANC) ? 500 within an eight-week period, or a clinically significant infection requiring IV antibiotics in the setting of ANC ? 1000 within the prior four months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Adequate organ function to permit RIC HSCT as indicated by the following:
  • Serum bilirubin ? 2.5 mg/dL (except when Gilbert's syndrome or MDS-related hemolysis suspected).
  • Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ? 2.5 times the upper limit of normal (ULN).
  • Serum creatinine ? 2.0 mg/dL.
  • Seemingly sufficient baseline cardiac function to undergo HSCT (no echocardiogram required).
  • Seemingly sufficient baseline pulmonary function to undergo HSCT (no pulmonary function tests required).
  • Seemingly sufficient neuro-psychiatric function to undergo HSCT (no specific neuro-psychiatric evaluation required).
  • Willingness to undergo human leukocyte antigen (HLA)-typing and consider subsequent HSCT.
  • Willingness and ability to give informed consent.

Exclusion Criteria

  • 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.

Gender

Both

Ages

60 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles David Avigan MD 617-667-9920 davigan@bidmc.harvard.edu
Dana Farber Cancer Institute - Boston, Massachusetts 2.6 miles Gregory A Abel MD MPH 617-632-2304 GAABEL@PARTNERS.ORG
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles YiBen Chen MD 617-726-1124 yachen@partners.org

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