Status:
ACTIVE_NOT_RECRUITING
Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Non-Neoplastic Hematologic and Lymphocytic Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
This phase II/III trial studies the best approach in improving quality of life and survival after a donor stem cell transplant in older, weak, or frail patients with blood diseases. Patients who have ...
Detailed Description
OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients undergo SPC on days -15 before to +56 after transplant. ARM II: Patients undergo a CMC program on days -15 before to +56 after transp...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT03870750
Start Date
August 15 2019
End Date
December 31 2025
Last Update
June 18 2025
Active Locations (11)
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1
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455