Your session is about to expire
← Back to Search
Other
Antihypertensive Therapy for Leukemia
Phase 2
Waitlist Available
Led By Seth E. Karol, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is 10 years of age or older at the time of enrollment on TOT17.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any time during leukemia therapy, approximately 2.5 years
Awards & highlights
Study Summary
This trial is comparing the frequency of radiographically extensive osteonecrosis in patients receiving intensive compared to conventional antihypertensive therapy.
Who is the study for?
This trial is for children and young adults over 10 years old with newly diagnosed acute lymphoblastic leukemia/lymphoma, who are not hypertensive. They must be able to undergo MRI scans, not have severe kidney issues or growth-altering syndromes, and agree to use contraception if applicable.Check my eligibility
What is being tested?
The study compares intensive antihypertensive therapy (aiming for lower blood pressure targets) versus conventional therapy (higher targets) in reducing osteonecrosis risk during leukemia/lymphoma treatment. It includes surveys, interviews, and monitoring of blood pressure and vascular health.See study design
What are the potential side effects?
Potential side effects may include dizziness or lightheadedness due to lowered blood pressure from the antihypertensive treatments. Other risks could relate to the individual's response to medication adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 10 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ any time during leukemia therapy, approximately 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~any time during leukemia therapy, approximately 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extensive radiographic osteonecrosis
Secondary outcome measures
Biomarker of vascular dysfunction - Arterial elasticity (ml/mmHg)
Biomarker of vascular dysfunction - D-dimer (µg/mL)
Biomarker of vascular dysfunction - E-selectin (ng/mL)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Antihypertensive TherapyExperimental Treatment3 Interventions
Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
Group II: Conventional Antihypertensive TherapyActive Control3 Interventions
Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,562 Total Patients Enrolled
1 Trials studying Osteonecrosis
17 Patients Enrolled for Osteonecrosis
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,221 Total Patients Enrolled
2 Trials studying Osteonecrosis
3,571 Patients Enrolled for Osteonecrosis
Seth E. Karol, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
990 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot walk due to long-term conditions, not because of recent leukemia/lymphoma complications.My kidney function is significantly reduced.I am 10 years old or older.I have completed up to 4 days of my current treatment plan.I have Down's syndrome or a condition that affects my growth or height.I am currently being treated for ALL following the TOT17 protocol.I am not pregnant or breastfeeding and agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Intensive Antihypertensive Therapy
- Group 2: Conventional Antihypertensive Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available in this research program?
"Affirmative. Per the clinicaltrials.gov website, this medical experiment has been recruiting since October 15th 2020 and is still actively looking for participants. Altogether 180 people need to be enrolled from 3 separate study locations."
Answered by AI
How many volunteers are engaged in this research effort?
"Correct. The records on clinicaltrials.gov reveal that this examination, which was first shared on October 15th 2020 is presently enrolling individuals. Around 180 candidates must be recruited from 3 distinct medical centres."
Answered by AI
To what extent can the Semi-structured interview be detrimental to a person's health?
"We rate the safety of semi-structured interview at a 2 as this is an experimental stage trial. While there has been some data attesting to its safety, efficacy remains unvalidated."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger