Improve Outcomes for Older Allogeneic Transplant Recipients

NCT05612789 | Recruiting

• 2 other identifiers: UPCC 07422Penn IRB# 851615
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional pilot study to determine whether implementation of a supervised exercise program can improve outcomes in subjects undergoing allogeneic HCT. The primary objective is to determine feasibility. Up to 60-72 evaluable subjects will be enrolled. Evaluable subjects are defined as those participating in the exercise intervention.

Conditions

Allogeneic Transplantation

Outcome Measures

Primary Outcomes (2)

• Proportion of enrolled subjects who participate in the supervised exercise program

  From 3 months prior to HCT to 100 days after HCT

• Median number of exercise sessions delivered pre-HCT and post-HCT.

  From 3 months prior to HCT to 100 days after HCT

Secondary Outcomes (5)

• Hospital LOS for HCT

  From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months

• Rate of readmission

  From time of discharge from initial hospital stay up through 1-2 years after HCT

• 6-month and 1-year overall mortality

  From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS

• 1-year and 2-year OS

  From day 0 of HCT to 1-year and 2-years

• 1-year and 2-year PFS

  From day 0 of HCT to 1-year and 2-years

Study Arms (2)

Cohort A (Prehab)

EXPERIMENTAL

Pre-frail and frail subjects will attend at least twice weekly exercise sessions with a physical therapist and be given an exercise program to complete at home prior to admission for HCT. Patients enrolled in this cohort can continue on to Cohort B.

Behavioral: Exercise Program (Cohort A Prehab)

Cohort B (Rehab)

EXPERIMENTAL

All patients 60 years and older upon discharge from their initial hospital stay for HCT will attend at least weekly exercise sessions with a physical therapist and be given an exercise program to complete at home with sessions continued through Day +100 after HCT.

Behavioral: Exercise Program (Cohort B Rehab)

Interventions

Exercise Program (Cohort A Prehab) BEHAVIORAL

Pre-frail and frail potential HCT recipients 60 years and older will participate in a supervised exercise program from the time of enrollment up until HCT admission. Exercise compliance will be measured in part through physical activity trackers.from time of discharge from HCT until day +100 post-HCT. All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.

Cohort A (Prehab)

Exercise Program (Cohort B Rehab) BEHAVIORAL

All HCT recipients 60 years and older will participate in a supervised exercise program from the time of discharge from HCT admission until day +100 post-HCT. Exercise compliance will be measured in part through physical activity trackers.

Cohort B (Rehab)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A (Prehab)
• Age 60 years or older.
• Planned allogeneic HCT in the next 1-6 months.
• Hematological malignancy as the indication for HCT.
• Pre-frail or frail by Fried frailty phenotype.
• Cohort B (Rehab)
• Age 60 years or older.
• Planned allogeneic HCT or HCT within the last 30 days.
• Hematological malignancy as the indication for HCT.

You may not qualify if:

• Cohorts A and B
• \. Comorbid disability or illness that prevents safe exercise.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Shannon McCurdy, MD

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqui Rick

CONTACT

2152209675; Jacqui.Rick@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 10, 2022
• Study Start: February 15, 2023
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)