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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post transplant
Awards & highlights
No Placebo-Only Group

Study 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.

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

Awards & Highlights

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

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
1,920 Previous Clinical Trials
2,293,704 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

Frequently Asked Questions

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

What conditions are typically addressed by the Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa and melphalan?

"Alemtuzumab, fludarabine, thiotepa and melphalan can be used as a transplant preparative regimen to treat multiple sclerosis. It is also known to successfully manage cancer, rejection of transplants, kidney issues and b-lymphocyte related disorders."

Answered by AI

What prior investigations have been conducted on the effects of combining alemtuzumab, fludarabine, thiotepa and melphalan as part of an organ Transplant preparative regimen?

"Alemtuzumab, fludarabine, thiotepa and melphalan was first tested as a transplant preparative regimen in 1997 at the City of Hope Comprehensive Cancer Center. Since then there have been 665 trials completed with an additional 481 active clinical sites - many located within Saint Louis, Missouri."

Answered by AI

Has the US Food and Drug Administration sanctioned a Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan?

"With evidence of safety but no proof of efficacy, our team at Power assigned Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa and melphalan a score of 2 on the risk scale."

Answered by AI

How many individuals have enrolled in the clinical trial to date?

"Yes, according to the information on clinicaltrials.gov, this medical trial is actively seeking enrolment from patients at present. It was first posted on March 1st 2013 and has been amended as recently as April 25th 2022. The experiment requires 20 participants divided between two sites for proper data collection."

Answered by AI

Is this experiment accessible to prospective participants at the moment?

"As per the information hosted on clinicaltrials.gov, this study is currently recruiting patients for participation. It was first advertised on March 1st 2013 and more recently updated April 25th 2022."

Answered by AI
~4 spots leftby Mar 2027