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Monoclonal Antibodies
Melphalan for Sickle Cell Disease
Phase 3
Waitlist Available
Led By Jennifer Krajewski, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient Eligibility
Hb SS, S-thal0, S-thal+, SC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will be investigating the use of stem cell transplantation to cure sickle cell disease.
Eligible Conditions
- Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Graft Failure
Secondary outcome measures
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Related donorExperimental Treatment4 Interventions
Matched sibling donors (9-10/10 marrow/PBSC or 5-6/6 UCB (single) with a total TNC dose of greater than 5 x 107/kg recipient weight), age 2-30 years after conditioning regimen Alemtuzumab , Fludarabine, and Melphalan.
1) Patients will receive a conditioning regimen composed of Alemtuzumab, Fludarabine, and Melphalan as detailed in the table below.
Day Treatment
-22 Alemtuzumab 3mg IV (test dose)
-21 Alemtuzumab 10mg IV
-20 Alemtuzumab 15mg IV
-19 Alemtuzumab 20mg IV
-8 Fludarabine 30mg/m2 IV
-7 Fludarabine 30mg/m2 IV
-6 Fludarabine 30mg/m2 IV
-5 Fludarabine 30mg/m2 IV
-4 Fludarabine 30mg/m2 IV
-3 Melphalan 140mg/m2 IV
-2 Rest Day
-1 Rest Day
0 Stem Cell Infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
2004
Completed Phase 4
~1890
Fludarabine
2012
Completed Phase 3
~1090
Melphalan
2008
Completed Phase 3
~1500
Stem Cells
2012
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,214 Total Patients Enrolled
Jennifer Krajewski, MDPrincipal InvestigatorHackensack Meridian Health
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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