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CAR T-cell Therapy

Exercise for Blood Cancer (Allo-X Trial)

Phase < 1

Recruiting

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be between 21 and 55 years of age

Be between 18 and 65 years old

Must not have

Participants with known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast

Participants with chronic or debilitating arthritis or have been bedridden in the past three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120-days

Summary

"This trial aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. The study will test whether exercise can help produce better immune cells for cancer patients who receive immune cell

Who is the study for?

This trial is for healthy individuals who can donate immune cells to help improve blood cancer treatments. It's not specified, but typically participants should be adults, in good health, and able to perform exercise or take medications as required by the study.

What is being tested?

The trial tests if exercise or certain drugs (beta blockers and isoproterenol) can produce healthier immune cells from donors for cell therapies used in treating blood cancers like lymphoma and leukemia. The study has three groups: one exercising, one taking beta blockers with exercise, and one receiving a drug mimicking adrenaline effects.

What are the potential side effects?

Possible side effects may include reactions to beta blockers such as fatigue, dizziness or gastrointestinal issues; responses to isoproterenol like rapid heartbeat; and general discomfort from exercise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart issues or can't take certain heart medications.

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I have severe arthritis or have been bedridden recently.

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I am currently using tobacco or quit less than 6 months ago.

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I have HIV, hepatitis, or an autoimmune disease.

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I am taking prescription medication or am allergic to beta-blockers.

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I am scheduled for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical xGvHD Score

Cytolysis in vitro

Immune Cell Enumeration and Phenotyping

+2 more

Secondary study objectives

CITE-Seq Analysis of Immune Cell Populations

Human Cell Engraftment and Immune Reconstitution

Pathology and Immunohistochemistry

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Isoproterenol Infusion CohortExperimental Treatment1 Intervention

To determine if pharmacological activation of beta-adrenergic receptors evokes an immune respponse akin to exercise, healthy participants will receive an intravenous infusion of isoproterenol (50ng/kg/min)

Group II: Exercise CohortExperimental Treatment1 Intervention

After an initial maximal graded exercise test to determine maximal oxygen uptake and peak cycling power, healthy participants will undergo a 20-minute graded exercise test at intensities corresponding to 50, 60, 70 and 80% VO2max (5-minutes per stage)

Group III: Exercise + Beta Blocker CohortPlacebo Group5 Interventions

Healthy participants will complete a 20-minute graded exercise test at intensities ranging from 50-80-% of the maximal oxygen uptake under the following conditions: (1) Placebo; (2) 10mg bisoprolol ingestion; (3) 80ng nadolol ingestion; (4) 50ng carvedilol ingestion; (5) 10mg bisoprolol + 100mcg roflumilast ingestion. All drugs and placebo will be ingested 2-3h prior to exercise. Trial conditions will be double-blind and cross over with each participant serving as their own cntrol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

Isoproterenol

2015

Completed Phase 3

~22740