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Monoclonal Antibodies

Transplant Conditioning Regimen for Blood Disorders

Phase 1 & 2
Recruiting
Led By Shalini Shenoy, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If sickle cell, Hemoglobin S must be less than 30%
Stratum 1: Patient must have a non-malignant disorder, excluding thalassemia, and must be receiving a 8/8 HLA-matched bone marrow, related or unrelated
Must not have
Invasive infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to prepare for a bone marrow transplant that may be less intense and have fewer side effects.

Who is the study for?
This trial is for children and young adults under 21 with non-cancerous blood, bone marrow, or metabolic disorders. They must have a matched donor for bone marrow or umbilical cord blood transplant and be in good health otherwise. Pregnant individuals, those with HIV, or active infections cannot participate.
What is being tested?
The study tests a new transplant conditioning regimen that uses Campath (an immunosuppressive drug), Fludarabine (a chemotherapy agent), and Melphalan (another chemotherapy) to prepare patients' bodies to accept donor cells without fully destroying their own bone marrow.
What are the potential side effects?
Potential side effects may include immune system suppression leading to increased infection risk, reactions related to the infusion of drugs, organ inflammation due to strong medications used in the treatment plan, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Hemoglobin S level is below 30%.
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I have a non-cancerous condition and am getting a fully matched bone marrow transplant.
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I have thalassemia and am getting a closely matched bone marrow or cord blood transplant.
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I have a non-cancerous condition and am getting a closely matched bone marrow or cord blood transplant.
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I am under 21 years old.
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I can carry out daily activities with some help or on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Donor engraftment as measured by chimerism
Major toxicities as graded by the CTC v4
Secondary study objectives
Immune reconstitution by laboratory evaluations
Incidence of acute graft-versus-host disease as measured by protocol grading scale
Graft-vs-Host Disease
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Stratum 4Experimental Treatment3 Interventions
Recipient with non-malignant disorder, excluding hemoglobinopathy Related or unrelated. 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB
Group II: Stratum 3Experimental Treatment3 Interventions
Recipient with hemoglobinopathy Related or unrelated. 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB
Group III: Stratum 2Experimental Treatment3 Interventions
Recipient with transfusion dependent thalassemia. Related or unrelated. 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB
Group IV: Stratum 1Experimental Treatment2 Interventions
Recipients with non-malignant disorders, excluding thalassemia. Related or unrelated 8/8 HLA-matched bone marrow

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,042 Total Patients Enrolled
St. Louis Children's HospitalOTHER
29 Previous Clinical Trials
87,602 Total Patients Enrolled
Shalini Shenoy, MDPrincipal InvestigatorWashington University School of Medicine (in St. Louis)
2 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Campath (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00920972 — Phase 1 & 2
Non-Malignant Disorders Research Study Groups: Stratum 1, Stratum 2, Stratum 3, Stratum 4
Non-Malignant Disorders Clinical Trial 2023: Campath Highlights & Side Effects. Trial Name: NCT00920972 — Phase 1 & 2
Campath (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00920972 — Phase 1 & 2
~17 spots leftby Dec 2026
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