Leukemia, AcuteNCT03680677
Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
An observational study of Leukemia, Acute and MDS, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Acute, MDS
- What is being tested?
- Bone Marrow or Peripheral Blood Graft (BMT) and Frailty Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to Nov 2027
- Phase
- Observational
- 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
Study population: Two cohorts of patients will be included in this analysis. Arm A will include patients 60 years of age and older with a new diagnosis of either acute leukemia or MDS who are being evaluated either in the outpatient or inpatient hematologic malignancies department at the University of Pennsylvania. Arm B will include patients 60 years of age and older with a diagnosis of any hematologic malignancy being treated with cellular therapy including allogeneic blood or marrow transplantation or CAR T-cells.
Eligibility Criteria Arm A:
- Age 60 years or older.
- New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
- Able to consent to the study.
Eligibility Criteria Arm B:
- Age 60 years or older with a hematologic malignancy.
- Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.
- Able to consent to the study.
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
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.
- Conditions
- Leukemia, Acute, MDS
- Being tested
- Bone Marrow or Peripheral Blood Graft (BMT), Cancer-directed Therapy or Best Supportive Care, Frailty Assessment
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow or Peripheral Blood Graft (BMT)Procedure or surgery
Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.
Cancer-directed Therapy or Best Supportive CareOther
Cancer-directed therapy with intensive regimens ("7+3," Vyxeos, clofarabine, or similar), clinical trial, hypomethylating agent (azacitidine or decitabine), hypomethylating agent combinations (i.e. with venetoclax, sorafenib, enasidenib, ivosidenib, midostaurin, gilteritinib, or other targeted agent), targeted agents alone (i.e. enasidenib, ivosidenib, gilteritinib, midostaurin, etc.), or supportive care.
Frailty AssessmentDiagnostic test
Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Directed Therapy or Best Supportive Care | Cancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care Receives: Other: Cancer-directed Therapy or Best Supportive Care; Diagnostic Test: Frailty Assessment | |
| Transplant | Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy Receives: Procedure: Bone Marrow or Peripheral Blood Graft (BMT); Diagnostic Test: Frailty Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
NRM will be defined as death without evidence of disease progression or relapse.
Measured: 1-month
Secondary outcomes (1)
NRM by Intensity of Treatment
NRM of frail and pre-frail patients by intensity of treatment
Measured: 1-month and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start21 Sep 2018
- Primary completion30 Sep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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, Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680677
- Sponsor's protocol ID
- UPCC 06718
- Other IDs
- 831340
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2018
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03680677
- Acronym / sponsor ID
- UPCC 06718
- Conditions
- Leukemia, Acute, MDS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Sep 2018 (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.
The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Directed Therapy or Best Supportive Care | – | Other: Cancer-directed Therapy or Best Supportive Care, Diagnostic Test: Frailty AssessmentCancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care |
| Transplant | – | Procedure: Bone Marrow or Peripheral Blood Graft (BMT), Diagnostic Test: Frailty AssessmentBone marrow or peripheral blood graft (BMT) or CAR T-cell therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts of patients will be included in this analysis. Arm A will include patients 60 years of age and older with a new diagnosis of either acute leukemia or MDS who are being evaluated either in the outpatient or inpatient hematologic malignancies department at the University of Pennsylvania. Arm B will include patients 60 years of age and older with a diagnosis of any hematologic malignancy being treated with cellular therapy including allogeneic blood or marrow transplantation or CAR T-cells.
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 |
|---|---|---|
| Bone Marrow or Peripheral Blood Graft (BMT)Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol. | Procedure or surgery | Transplant |
| Cancer-directed Therapy or Best Supportive CareCancer-directed therapy with intensive regimens ("7+3," Vyxeos, clofarabine, or similar), clinical trial, hypomethylating agent (azacitidine or decitabine), hypomethylating agent combinations (i.e. with venetoclax, sorafenib, enasidenib, ivosidenib, midostaurin, gilteritinib, or other targeted agent), targeted agents alone (i.e. enasidenib, ivosidenib, gilteritinib, midostaurin, etc.), or supportive care. | Other | Cancer Directed Therapy or Best Supportive Care |
| Frailty AssessmentFrailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors. | Diagnostic test | Cancer Directed Therapy or Best Supportive Care, Transplant |
Primary outcome
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
Time frame: 1-month
NRM will be defined as death without evidence of disease progression or relapse.
1 secondary outcome
NRM by Intensity of Treatment
Time frame: 1-month and 6-month
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 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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
Abramson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Acute and MDS, 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?
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 12 Aug 2026. 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 Shannon McCurdy, MD (855-216-0098, penncancertrials@emergingmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients (time frame: 1-month). 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 12 Aug 2026.