Recruiting

Frailty Assessments

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT03680677

Conditions

Leukemia, Acute

MDS

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow or Peripheral Blood Graft (BMT)

Cancer-directed Therapy or Best Supportive Care

Frailty Assessment

Study Details

Brief 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.

Conditions

Leukemia, Acute

MDS

Study ID

NCT03680677

Start date

Sep 21, 2018

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Transplant

Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy

Interventions

Bone Marrow or Peripheral Blood Graft (BMT)

Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

Cancer-directed Therapy or Best Supportive Care

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 Assessment

Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.

Primary outcome measure

  • Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients [ Time Frame: 1-month ]

Central Contacts and Locations

Central contacts

Shannon McCurdy, MD

855-216-0098penncancertrials@emergingmed.com

Locations

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-08-12.