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Monoclonal Antibodies

Avastin and/or Gleevec for PVOD (PVS Trial)

Phase 1 & 2
Waitlist Available
Led By Kathy J Jenkins, MD, MPH
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 20 Other Conditions

Summary

The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.

Eligible Conditions
  • PVOD

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Number of Patients With Disease Progression at 48 Weeks

Side effects data

From 2015 Phase 1 & 2 trial • 50 Patients • NCT00891527
100%
Blood Bone Marrow Suppression
85%
Other
67%
Liver Toxicity
65%
Renal Toxicity
56%
Gastrointestinal Toxicity
46%
Infection
27%
Rash
13%
Transfusion
4%
Bone Marrow Suppression
4%
Hospitalization
2%
Tremors
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avastin and/or Gleevec

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Avastin and/or GleevecExperimental Treatment1 Intervention
Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
FDA approved

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
786 Previous Clinical Trials
5,582,291 Total Patients Enrolled
Kathy J Jenkins, MD, MPHPrincipal InvestigatorBoston Children's Hospital
~3 spots leftby Nov 2025
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