Non Hodgkin Lymphoma Clinical Trial

Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

Summary

This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.

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Full Description

PRIMARY OBJECTIVES:

I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.

II. Define the determinants of VO2peak impairment in HCT survivors.

OUTLINE:

Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.

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Eligibility Criteria

Inclusion Criteria:

Age at HCT >= 18 years
Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
Planning to undergo first autologous or allogeneic transplant
Able to fluently read and write in English
Able to understand and sign the study specific informed consent form (ICF)
Physically able and willing to complete all study procedures

Exclusion Criteria:

Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)
Recurrent syncope
Acute myocarditis or pericarditis
Symptomatic severe aortic stenosis
Uncontrolled arrhythmia causing symptoms
Pulmonary embolus < 3 month of study procedures
Thrombosis of lower extremities
Moderate or severe persistent asthma (National Asthma Education & Prevention)
Room air desaturation at rest =< 85%
Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
Anemia (hemoglobin [Hgb] < 8 g/dL)

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

350

Study ID:

NCT04537871

Recruitment Status:

Recruiting

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Saro H. Armenian
Contact
626-359-8111
[email protected]
Saro H. Armenian
Principal Investigator

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Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

350

Study ID:

NCT04537871

Recruitment Status:

Recruiting

Sponsor:


City of Hope Medical Center

How clear is this clinincal trial information?

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