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 with Hematological Diseases

Cancer Categories

Hematologic (Blood Cancers)

Karmanos Trial ID

2020-069

NCT ID

NCT03870750

Age Group

Adult

Scope

National

Phase

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)

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Eligibility

Inclusion Criteria:

Vulnerable patients as defined by one or more of the following criteria

Age 65 years or older
Having Hematopoietic Cell Transplantation - Comorbidity Index (HCT-CI) scores of >= 3 (for patients that could be 20 years old and older)
Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients 50 years old and older)

Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease
Able to speak and read English - interaction with the interventionist trainer and endpoint measurement must occur in English
Willing and able to provide informed consent
Planned allogeneic HCT within 3 weeks - all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g. suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant
Able to exercise at low to moderate intensity, specifically taking into consideration the rare circumstances where subjects are not able to exercise due to either birth deformity or prior traumatic injury that affects their gait
Adequate cardiopulmonary reserve, as judged by data from the patient's electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment

Exclusion Criteria:

Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility
Participation in another intervention clinical trial with HRQOL as a primary endpoint
Planned donor lymphocyte infusion (DLI) within 90 days post-transplant
Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol principal investigator (PI)

Locations

Karmanos Cancer Institute - Detroit Headquarters

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

Applicable Disease Site

Therapies, Drugs, Devices