Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

  • STATUS
    Recruiting
  • End date
    Feb 7, 2023
  • participants needed
    32
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 7 May 2021

Summary

This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive.

Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.

Description

This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning.

  1. HCT-CI/Age 4 AND no IADL impairment (less vulnerable/fit) -> MA regimen
  2. HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> RIC/NMA regimen
    • Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
    • Radiation therapy: total body irradiation (TBI)
    • Other therapy: anti-thymocyte globulin (ATG)

Details
Condition Bone marrow disorder, Chronic myelomonocytic leukemia, Juvenile Myelomonocytic Leukemia, Preleukemia, Philadelphia-Negative Myelogenous Leukemia, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), Myeloproliferative Neoplasms, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, atypical chronic myeloid leukemia, myelodysplastic syndrome (mds), chronic myelomonocytic leukaemia, cmml, Myelodysplastic/Myeloproliferative Overlapping Syndrome, Myelodysplastic/Myeloproliferative Overlapping Syndrome, Myelodysplastic/Myeloproliferative Overlapping Syndrome, Myelodysplastic/Myeloproliferative Overlapping Syndrome
Treatment Conditioning regimen, Geriatric assessment (GA) pre-transplant, Allogeneic CD34+ selected stem cells
Clinical Study IdentifierNCT04761770
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have any of these conditions: myelodysplastic syndromes or Chronic myelomonocytic leukemia or MYELODYSPLASTIC SYNDROME or Myelodysplastic Syndromes (MDS) or atypical chronic myeloi...?
Do you have any of these conditions: Myeloproliferative Neoplasms or chronic myelomonocytic leukaemia or Juvenile Myelomonocytic Leukemia or myelodysplastic syndrome (mds) or Myelodysplas...?
Do you have any of these conditions: cmml or myeloproliferative neoplasm or Myelodysplastic/Myeloproliferative Overlapping Syndrome or myelodysplastic syndromes or chronic myelomonocytic ...?
Do you have any of these conditions: myeloproliferative neoplasm or Philadelphia-Negative Myelogenous Leukemia or atypical chronic myeloid leukemia or Bone marrow disorder or MYELODYSPLAS...?
are 60 years or older
have pathologically confirmed myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
have <10% blasts in bone marrow prior to transplant
have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician

Exclusion Criteria

Prior hematopoietic cell transplantation
Cord blood donors
Persons with active, refractory disease defined by 10% blasts in bone marrow prior to transplant
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