Details

Details

Title Feasibility and Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) Compared to Conventional Therapy for Older and Medically Infirm Patients Diagnosed with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes: A Prospective Observational Study

IRB FHCRC1913

CC 14-207

Hospital Main Campus

Phase Phase 4

Disease Leukemia - Acute Myeloid (AML), Myelodisplastic Syndrome (MDS)

Description

Description

Primary Objectives
  • Feasibility of allogeneic HCT in older and medically infirm patients with AML
    • Estimating the probability of undergoing allogeneic HCT among older and medically infirm AML patients compared to younger and relatively healthier patients.
    • Comparing the characteristics of patients who did versus did not proceed to allogeneic HCT.
  • Comparison of outcomes among prospectively enrolled older and medically infirm AML patients given allogeneic HCT versus induction therapy
    • Non-relapse mortality (NRM), overall (OS), and disease-free survival (DFS).
    • QOL
Secondary Objectives
  • Among a subset of patients, studying the impacts of some pulmonary function tests (diffusion capacity of carbon monoxide, and forced expiratory volume in one second) and plasma biomarkers (C-reactive protein, albumin, ferritin, and vitamin D) on:
    • Overall mortality at 8 weeks after induction therapy
    • Feasibility of allogeneic HCT
    • Comparison of outcomes between allogeneic HCT versus conventional therapy
Inclusion Criteria

Inclusion Criteria

  1. Patients with new diagnoses of non-M3 AML (See study document '2008 WHO Classification of AML') or high-risk MDS (showing 10% or more blasts in bone marrow) (See study document '2008 WHO Classification and Criteria for MDS') who:
    • Present for an AML-like treatment that could plausibly produce a complete remission (CR); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy
    • Explicitly intend to establish follow-up care at one of the collaborating institutions.
  2. Patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed
  3. Patients of ≥ 18 years of age and are being treated by the adult AML service.
  4. Able to speak and read English.
  5. Willing and able to provide informed consent.
Exclusion Criteria

Exclusion Criteria

  1. Patients of ≤ 17 years of age or who are ≥ 18 and receive treatment under the pediatric AML service.
  2. Patients older than 80 years
  3. Patients with < 6 months projected survival due to active second malignancy or other medical problem.