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Anti-thrombotic agent

Supportive Care (defibrotide) for Neuroblastoma

Q: Is it possible for patients to enroll in this ongoing clinical trial?

According to the latest update on clinicaltrials.gov, this particular research study is not actively seeking participants. Its initial posting was made on March 1st, 2024 and it was last edited on December 13th, 2023. However, it's worth noting that there are currently a total of 281 other ongoing clinical trials actively recruiting patients at this time.

Q: Can individuals who have reached or exceeded the age of 65 participate in this trial?

To meet the eligibility requirements for this research study, participants must be at least 1 year old but not exceed 18 years of age.

Q: Are there any potential risks or adverse effects associated with the use of Supportive Care (defibrotide) in individuals?

Given that this trial is in Phase 2, there is limited safety data available for Supportive Care (defibrotide). Therefore, it has been assigned a safety rating of 2.

Phase 2

Waitlist Available

Led By Christine Higham, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Age: 1 - < 18 years old

Planned tandem transplants with conditioning with cyclophosphamide-thiotepa and carboplatin-etoposide-melphalan on, or as per, NCT03126916 (ANBL1531) or other tandem-containing COG high-risk neuroblastoma trials

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to1 year

Awards & highlights

Study Summary

This trial is testing a medication called defibrotide to see if it can prevent a dangerous complication called transplant-associated thrombotic microangiopathy (TA-TMA) in patients with high-risk neuro

Who is the study for?

This trial is for patients with high-risk neuroblastoma who are undergoing tandem stem cell transplants. It aims to prevent a serious complication called transplant-associated thrombotic microangiopathy (TA-TMA), which can occur after receiving chemotherapy that damages blood vessels.Check my eligibility

What is being tested?

The trial is testing the effectiveness of defibrotide in preventing TA-TMA. Defibrotide may protect blood vessel walls from damage caused by chemotherapy, potentially reducing the risk of TMA and its associated organ damage, especially in kidneys.See study design

What are the potential side effects?

Defibrotide's side effects could include bleeding complications due to its anticoagulant properties, as well as possible allergic reactions or other infusion-related responses. The exact side effect profile will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 1 and 17 years old.

Select...

I am scheduled for specific chemotherapy as part of a neuroblastoma study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative incidence of transplant-associated thrombotic microangiopathy (TA-TMA)

Secondary outcome measures

Cumulative incidence of severe TA-TMA

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02876601

81%

Headache

38%

Flu-like Symptoms

19%

Chills

13%

Nausea

13%

Arthralgia

Precollapse

Dizziness

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Defibrotide Plus LPS

Placebo Plus LPS

Defibrotide Plus Placebo

Placebo/Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (defibrotide)Experimental Treatment1 Intervention

Participants receive defibrotide IV over 2 hours every six hours on days -8 to +21 during the first and second rounds of Hematopoietic stem-cell transplantation (HSCT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Defibrotide

2018

Completed Phase 4

~2490

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsIndustry Sponsor

248 Previous Clinical Trials

34,229 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,525 Total Patients Enrolled

6 Trials studying Neuroblastoma

3,961 Patients Enrolled for Neuroblastoma

Christine Higham, MDPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for patients to enroll in this ongoing clinical trial?

"According to the latest update on clinicaltrials.gov, this particular research study is not actively seeking participants. Its initial posting was made on March 1st, 2024 and it was last edited on December 13th, 2023. However, it's worth noting that there are currently a total of 281 other ongoing clinical trials actively recruiting patients at this time."

Answered by AI

Can individuals who have reached or exceeded the age of 65 participate in this trial?

"To meet the eligibility requirements for this research study, participants must be at least 1 year old but not exceed 18 years of age."

Answered by AI

Are there any potential risks or adverse effects associated with the use of Supportive Care (defibrotide) in individuals?

"Given that this trial is in Phase 2, there is limited safety data available for Supportive Care (defibrotide). Therefore, it has been assigned a safety rating of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Defibrotide Prophylaxis of Transplant Associated-Thrombotic Microangiopathy for Neuroblastoma

2024. "Defibrotide Prophylaxis of Transplant Associated-Thrombotic Microangiopathy for Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182410.

All > Neuroblastoma