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  • A Seamless Phase II-Phase III Randomized Clinical Trial to Identify and Confirm the Most Promising Novel Intervention to Alleviate Morbidity and Mortality after Allogeneic Hematopoietic Cell Transplantation Among Older, Medically Infirm, or Frail Patients

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2020-069
    NCT ID
    • NCT03870750
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II/III
    Principal Investigator
    • Joseph
      Uberti, M.D., Ph.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective (Phase II): Compare in a randomized phase II study the effectiveness of supportive and palliative care, a clinical multi-modal program, or a combined approach versus UCO to determine the winning arm in improving HRQOL (Day-90 FACT-BMT scores) for vulnerable recipients of allogeneic HCT.

    Secondary Objectives (Phase II):
    • Compare each of the three arms versus UCO regarding:
    • Rates of overall survival
    • Cumulative incidences of NRM
    • Cumulative incidences of relapse
    • Rates of relapse-free survival (RFS)
    • Cumulative incidence of frailty
    • Cumulative incidence of disability
    • Cumulative incidence of grades III-IV cardiac, hepatic, pulmonary and renal toxicities according to the CTC version 4 (See study document: Adapted CTC)
    • Use of resources within first 90 days after HCT:
    • Frequency of hospitalization
    • Duration of each hospitalization
    • Number and duration of admissions to intensive care unit
    • Days out of hospital alive (DOHA)

    Primary Objective (Phase III):Compare in a randomized phase III study the effectiveness of the winning arm from the preceding phase II study versus UCO in improving HRQOL (Day-90 FACT-BMT scores) and/or overall survival at 1-year for vulnerable recipients of allogeneic HCT.

    Secondary Objectives (Phase III):
    Compare the two arms regarding
    • Rates of overall survival
    • Cumulative incidences of NRM
    • Cumulative incidences of relapse
    • Rates of relapse-free survival (RFS)
    • Cumulative incidence of frailty
    • Cumulative incidence of disability
    • Use of resources within first 90 days after HCT:
    • Frequency of hospitalization
    • Duration of each hospitalization
    • Number and duration of admissions to intensive care unit
    • Days out of hospital alive (DOHA)
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266