Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies

NCT03680677 | Recruiting DMC

• 2 other identifiers: UPCC 06718831340
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1-month

Secondary Outcomes (1)

• NRM by Intensity of Treatment

  1-month and 6-month

Study Arms (2)

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

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

Procedure: Bone Marrow or Peripheral Blood Graft (BMT); Diagnostic Test: Frailty Assessment

Interventions

Bone Marrow or Peripheral Blood Graft (BMT) PROCEDURE

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

Transplant

Cancer-directed Therapy or Best Supportive Care OTHER

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.

Cancer Directed Therapy or Best Supportive Care

Frailty Assessment DIAGNOSTIC_TEST

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

Cancer Directed Therapy or Best Supportive Care; Transplant

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Shannon McCurdy, MD

  Abramson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon McCurdy, MD

CONTACT

855-216-0098; penncancertrials@emergingmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 21, 2018
• Study Start: September 21, 2018
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)