Improve Outcomes for Older Allogeneic Transplant Recipients

Allogeneic Transplantation Clinical Trial

Official title:

Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612789
• Other study ID #: UPCC 07422
• Secondary ID: Penn IRB# 851615
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Jacqui Rick
• Phone: 2152209675
• Email: Jacqui.Rick[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Transplantation

Intervention

Behavioral:
• Exercise Program (Cohort A Prehab)
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.
• Exercise Program (Cohort B Rehab)
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.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of enrolled subjects who participate in the supervised exercise program		From 3 months prior to HCT to 100 days after HCT
Primary	Median number of exercise sessions delivered pre-HCT and post-HCT.		From 3 months prior to HCT to 100 days after HCT
Secondary	Hospital LOS for HCT		From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
Secondary	Rate of readmission		From time of discharge from initial hospital stay up through 1-2 years after HCT
Secondary	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
Secondary	1-year and 2-year OS		From day 0 of HCT to 1-year and 2-years
Secondary	1-year and 2-year PFS		From day 0 of HCT to 1-year and 2-years