# Novel Intervention Approaches to Alleviate Allogeneic Transplant-Related Morbidity and Mortality

> **NIH NIH R01** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $690,341

## Abstract

Project Summary/Abstract
BACKGROUND: Hematological malignancies (HM) are rare cancers that affect the blood and lymph system
and can only be cured with transplantation of donor stem cells; namely allogeneic hematopoietic cell
transplantation (HCT). While advancements have improved outcomes for younger and otherwise healthy
patients, HCT can have devastating effects on the health-related quality of life (HRQOL) for older and
medically infirm (vulnerable) patients with HM. We were the first to develop an HCT-specific comorbidity index
(HCT-CI) that specifically showed that those with high scores can suffer from significant impairments in
HRQOL and higher rates of morbidity and mortality after HCT compared to patients with lower comorbidity
scores. Guided by our and others’ preliminary studies, we propose here to randomize those vulnerable patients
between supportive and palliative care, clinical management targeting specific comorbidities, both approaches
combined, vs. standard of care (SOC) to see which intervention can improve HRQOL of those patients after
HCT. OBJECTIVES: (1) Evaluate in a randomized phase II study the effectiveness of the four approaches
mentioned above in improving day-90 HRQOL for vulnerable recipients of allogeneic HCT; (2) determine in a
phase III study whether the winner arm from phase II definitively improves HRQOL vs. SOC; and (3) compare
the interventions with respect to survival, additional patient-reported outcomes, and the use of resources.
METHODS: We will conduct a multi-center seamless phase II/III randomized clinical trial in five large transplant
centers. The seamless feature means patients used in the phase II analysis will be included in the phase III
analysis but that will only happen if phase II produces an intervention with a clear advantage over SOC. In Aim
1, we will enroll 300 patients who either have age of ≥65 years, HCT-CI scores of ≥3, and/or slow walk speed
as indication of frailty, two weeks before they start their allogeneic HCT. Each intervention arm will be
implemented over 10 weeks period, 2 weeks before and 8 weeks after HCT, to achieve the maximum benefit in
preparing patients for HCT and guiding them through the early phases of the procedure. Patients will be
randomly assigned to one of the four arms described above. If there is an intervention arm from phase II that
improves HRQOL, then we will continue to test that arm only against SOC in a phase III study. We will only
need an additional 300 vulnerable patients for phase III (total of 600 for phase II/III). In Aim 3, we will see if any
of the interventions can improve survival, other patient-reported outcomes, and/or the use of resources.
PATIENT OUTCOMES: This proposal is the first to compare these peri-transplant interventions in vulnerable
HM patients given HCT. Results can minimize the suffering and, if possible, prolong the lives of similar patients
in the future and world-wide. Results could also encourage physicians to offer transp...

## Key facts

- **NIH application ID:** 9775429
- **Project number:** 5R01CA227092-02
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Mohamed Sorror
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $690,341
- **Award type:** 5
- **Project period:** 2018-09-03 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9775429

## Citation

> US National Institutes of Health, RePORTER application 9775429, Novel Intervention Approaches to Alleviate Allogeneic Transplant-Related Morbidity and Mortality (5R01CA227092-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9775429. Licensed CC0.

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