Cardiovascular Function in Acute Leukemia

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03760237
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Anticipated Duration (Months): 59.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Acute; Leukemia, Lymphoid, Acute; Cardiotoxicity	Other: observation only

Detailed Description

Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cardiovascular Function in Leukemia Patients: an Observational Prospective Study
• Actual Study Start Date: Dec 10, 2018
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acute Leukemia Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.	Other: observation only; No intervention, observational study only

Outcome Measures

Primary Outcome Measures

1. Left Ventricular dysfunction [1 year]

   defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.

Secondary Outcome Measures

1. Incidence of Cardiovascular Events [1 year]

2. Incidence of Symptomatic Heart Failure [1 year]

3. Incidence of Cardiac Death and all mortality [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Older than 18 years of age,

• New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).

• Signed the informed consent form

Exclusion Criteria:

• Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03760237
• Other Study ID Numbers: UPCC48418
• First Posted: Nov 30, 2018
• Last Update Posted: Jun 2, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cardiotoxicity

Study Results

No Results Posted as of Jun 2, 2022