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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-21

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Leukemia, Acute MDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cancer-directed Therapy or Best Supportive Care

Intervention Type 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.

Frailty Assessment

Intervention Type DIAGNOSTIC_TEST

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

Transplant

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

Bone Marrow or Peripheral Blood Graft (BMT)

Intervention Type PROCEDURE

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

Frailty Assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Bone Marrow or Peripheral Blood Graft (BMT)

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Frailty Assessment

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No