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Monoclonal Antibodies

Haploidentical Transplant for Chronic Granulomatous Disease

Phase < 1
Recruiting
Led By Elizabeth M Kang, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are 4 65 years of age
Ability to comprehend and willingness to sign the informed consent or have a parent/guardian consent if the donor is a minor; assent being obtained from minors as appropriate
Must not have
Major anticipated illness or organ failure incompatible with survival from AlloPBSC transplant
Any history of any neurologic disorders or family history of such, unrelated to infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 mo, 1 year, 2 year, and 3 years post transplant.
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with CGD for whom stem cell transplant may be a cure and who do not have a perfectly matched donor, related or unrelated. The objective is to see if it is safe to use a related bone marrow donor who is only a partial match to a person with CGD, and to see how well drugs given to a person before and after transplant help the body accept the transplant.

Who is the study for?
This trial is for people aged 4-65 with Chronic Granulomatous Disease (CGD) who need a stem cell transplant but don't have a perfect donor match. They must be HIV negative, understand and agree to the study's requirements, and stay near the NIH for three months post-transplant with a companion.
What is being tested?
The trial tests if using partially matched related bone marrow donors is safe for CGD patients. It involves pre- and post-transplant drugs like Alemtuzumab, Busulfan, Cyclophosphamide, Sirolimus, and Total Body Irradiation to help the body accept the new cells.
What are the potential side effects?
Possible side effects include immune system reactions due to Alemtuzumab or other drugs used in transplantation which can cause infections or organ inflammation; chemotherapy-related nausea; fatigue from radiation; potential complications from mismatched donor cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I understand and am willing to sign the informed consent myself, or my parent/guardian will if I'm a minor.
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I have a related donor for a transplant, but we don't fully match.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major illnesses or organ failures that would prevent me from surviving a stem cell transplant.
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I have a personal or family history of neurological disorders not caused by infections.
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I've needed steroids for colitis control within the last month.
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I need ongoing treatment with specific medications for my colitis.
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I have had seizures, not caused by an infection.
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My Crohn's disease activity score is within the required range for adults or children.
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I am willing to share my information for the alemtuzumab program and have been approved to receive it.
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I do not have a closely matched donor for a transplant.
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I do not have any active infections that could interfere with a transplant.
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I need help with my daily activities due to my health condition.
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I am younger than 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 mo, 1 year, 2 year, and 3 years post transplant.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 mo, 1 year, 2 year, and 3 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
Engraftment - Chimerism
Secondary study objectives
Neutrophil
Overall Survival/Event-Free survival
Viral immune titrels

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: 1Experimental Treatment6 Interventions
This is a single arm open-label pilot study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 4
~1710
Alemtuzumab
2004
Completed Phase 4
~1880
Sirolimus
2013
Completed Phase 4
~2750
Cyclophosphamide
2010
Completed Phase 4
~2310
Total Body Irradiation
2006
Completed Phase 3
~820

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,804 Total Patients Enrolled
Elizabeth M Kang, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
11 Previous Clinical Trials
373 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03910452 — Phase < 1
Chronic Granulomatous Disease Research Study Groups: 1
Chronic Granulomatous Disease Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT03910452 — Phase < 1
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03910452 — Phase < 1
~19 spots leftby Jun 2034
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