Allogeneic TransplantationNCT05612789
Improve Outcomes for Older Allogeneic Transplant Recipients
A study testing Exercise Program (Cohort A Prehab) and Exercise Program (Cohort B Rehab) in people with Allogeneic Transplantation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Allogeneic Transplantation
- What is being tested?
- Exercise Program (Cohort A Prehab) and Exercise Program (Cohort B Rehab)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Age 60 years or older.
- Planned allogeneic HCT or HCT within the last 30 days.
- Hematological malignancy as the indication for HCT.
Who cannot join
- Cohorts A and B
- 1. Comorbid disability or illness that prevents safe exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn Medicine
Philadelphia, Pennsylvania, 19104
Jacqui Rick, 215-220-9675, Jacqui.Rick@pennmedicine.upenn.edu
About this study
Official title: Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients
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
- Being tested
- Exercise Program (Cohort A Prehab), Exercise Program (Cohort B Rehab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program (Cohort A Prehab)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise Program (Cohort B Rehab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled subjects who participate in the supervised exercise program
Measured: From 3 months prior to HCT to 100 days after HCT
Median number of exercise sessions delivered pre-HCT and post-HCT.
Measured: From 3 months prior to HCT to 100 days after HCT
Secondary outcomes (5)
Hospital LOS for HCT
Measured: From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
Rate of readmission
Measured: From time of discharge from initial hospital stay up through 1-2 years after HCT
6-month and 1-year overall mortality
Measured: From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS
1-year and 2-year OS
Measured: From day 0 of HCT to 1-year and 2-years
1-year and 2-year PFS
Measured: From day 0 of HCT to 1-year and 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start15 Feb 2023
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic TransplantationStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon McCurdy, MD, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612789
- Sponsor's protocol ID
- UPCC 07422
- Other IDs
- Penn IRB# 851615
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening on Frailty to Improve Outcomes for Older Allogeneic Transplant Recipients
- ClinicalTrials.gov ID
- NCT05612789
- Acronym / sponsor ID
- UPCC 07422
- Conditions
- Allogeneic Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Prehab) | Experimental | Behavioral: 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) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- Cohorts A and B
- 1. Comorbid disability or illness that prevents safe exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cohort A (Prehab) |
| 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. | Behavioural | Cohort B (Rehab) |
Primary outcome
Proportion of enrolled subjects who participate in the supervised exercise program
Time frame: From 3 months prior to HCT to 100 days after HCT
Median number of exercise sessions delivered pre-HCT and post-HCT.
Time frame: From 3 months prior to HCT to 100 days after HCT
5 secondary outcomes
Hospital LOS for HCT
Time frame: From date of randomization until the date of first documented discharge from the hospital, assessed up to 100 months
Rate of readmission
Time frame: From time of discharge from initial hospital stay up through 1-2 years after HCT
6-month and 1-year overall mortality
Time frame: From day 0 of HCT to 6 months and 1-year] 6. 1-year and 2-year OS
1-year and 2-year OS
Time frame: From day 0 of HCT to 1-year and 2-years
1-year and 2-year PFS
Time frame: From day 0 of HCT to 1-year and 2-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Yes
Related trials for Allogeneic Transplantation
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Enrolling by invitationPhase 2
Thiotepa + TBI + Fludarabine + Etoposide for Allo-HSCT in Patients With R/R or High-risk Acute Leukemia
Acute Leukemia, High Risk, Acute Leukemia Refractory
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon McCurdy, MD principal investigator
Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program (Cohort A Prehab) and Exercise Program (Cohort B Rehab) in people with Allogeneic Transplantation, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqui Rick (2152209675, Jacqui.Rick@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrolled subjects who participate in the supervised exercise program (time frame: From 3 months prior to HCT to 100 days after HCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.