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Monoclonal Antibodies

Stem Cell Transplant Prep Regimen for Immune Deficiency Disorders

Phase 2
Recruiting
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
</= 28 years of age
Performance status >/= 40
Must not have
Known diagnosis of HIV I/II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post transplant
Awards & highlights

Summary

This trial is testing a new, less intense immunosuppressive regimen to see if it can establish engraftment of donor hematopoietic cells while still being safe.

Who is the study for?
This trial is for people under 28 with certain immune disorders like DiGeorge Syndrome and Wiskott-Aldrich Syndrome. They must have normal organ function, a performance status of at least 40%, and a matched donor for cell transplant. People with HIV, uncontrolled infections, or who are pregnant/breastfeeding can't join.Check my eligibility
What is being tested?
The study tests whether a mix of drugs (alemtuzumab, fludarabine, thiotepa, melphalan) before a cell transplant can help the body accept new immune cells with manageable side effects in patients with immune deficiencies.See study design
What are the potential side effects?
Possible side effects include reactions to the drug infusion such as fever or chills; low blood counts leading to increased infection risk; liver issues; nausea; mouth sores; and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 28 years old or younger.
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I am mostly bedridden due to my health condition.
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I have a donor that matches the required criteria for a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with HIV.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with donor engraftment
Secondary outcome measures
Disease free survival
Major Transplant Related Toxicities
Number of participants with infectious complications
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PreparativeExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,538 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01821781 — Phase 2
DiGeorge Syndrome Research Study Groups: Preparative
DiGeorge Syndrome Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT01821781 — Phase 2
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01821781 — Phase 2
~4 spots leftby Mar 2027
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