Improve Outcomes for Older Allogeneic Transplant Recipients

Not Applicable

Recruiting

• Conditions: Allogeneic Transplantation
• Interventions: Behavioral: Exercise Program (Cohort A Prehab); Behavioral: Exercise Program (Cohort B Rehab)

• Registration Number: NCT05612789
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-10
• Study Start: 2023-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Cohort A (Prehab)

1. Age 60 years or older.
2. Planned allogeneic HCT in the next 1-6 months.
3. Hematological malignancy as the indication for HCT.
4. Pre-frail or frail by Fried frailty phenotype.

Cohort B (Rehab)

1. Age 60 years or older.
2. Planned allogeneic HCT or HCT within the last 30 days.
3. Hematological malignancy as the indication for HCT.

Exclusion Criteria

Cohorts A and B

1. Comorbid disability or illness that prevents safe exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A (Prehab)	Exercise Program (Cohort A Prehab)	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.
Cohort B (Rehab)	Exercise Program (Cohort B Rehab)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1-year and 2-year PFS	From day 0 of HCT to 1-year and 2-years
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
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
1-year and 2-year OS	From day 0 of HCT to 1-year and 2-years

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States