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Monoclonal Antibodies

Haploidentical Transplant for Chronic Granulomatous Disease

Q: Could you outline the previous research that has been conducted on Allogeneic peripheral blood stem cell therapies?

Presently, there are 962 clinical trials occurring with regards to Allogeneic peripheral blood stem cell. Of those studies, 172 of them have progressed to Phase 3. Although Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> is the hub for many such investigations, 29059 other medical sites across the world are running these tests.

Q: Is the trial open to any person aged thirty-five or below?

According to the trial's eligibility criteria, only those aged 4 to 65 can participate in this study. For individuals under 18 and over 65 there are 361 and 732 trials respectively that may be better suited.

Q: How many participants have been enrolled in this trial?

Affirmative. According to clinicaltrials.gov, this biomedical investigation is currently searching for applicants. The trial was initially launched on October 28th 2019 and has been amended as of July 16th 2022. 30 individuals must be recruited from a single site.

Q: To what conditions is Allogeneic peripheral blood stem cell therapy typically applied?

Allogeneic peripheral blood stem cells can be utilized to address issues such as <a href="https://www.withpower.com/clinical-trials/lung-cancer">lung cancer</a>, organ transplantation, and <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>.

Q: Is this research actively looking for participants?

Yes, the data on clinicaltrials.gov verifies that recruitment is currently in progress for this medical experiment. This research project was first listed on October 28th 2019 and its most recent update was made July 16th 2022. 30 participants are being sought from 1 site.

Q: Who is qualified to participate in this scientific investigation?

This study seeks 30 participants with granuloma between the ages of 4 and 65.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 mo, 1 year, 2 year, and 3 years post transplant.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 65 years old or older.

Select...

I understand and am willing to sign the informed consent myself, or my parent/guardian will if I'm a minor.

Select...

I have a related donor for a transplant, but we don't fully match.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 mo, 1 year, 2 year, and 3 years post transplant.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Engraftment - Chimerism

Secondary outcome measures

Neutrophil

Overall Survival/Event-Free survival

Viral immune titrels

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

Total Body Irradiation

2006

Completed Phase 3

~820

Busulfan

2008

Completed Phase 3

~1120

Alemtuzumab

2004

Completed Phase 4

~1890

Cyclophosphamide

1995

Completed Phase 3

~3770

Sirolimus

2013

Completed Phase 4

~2750

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,439 Total Patients Enrolled

Elizabeth M Kang, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

11 Previous Clinical Trials

364 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

Frequently Asked Questions

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

Could you outline the previous research that has been conducted on Allogeneic peripheral blood stem cell therapies?

"Presently, there are 962 clinical trials occurring with regards to Allogeneic peripheral blood stem cell. Of those studies, 172 of them have progressed to Phase 3. Although Philadelphia, Pennsylvania is the hub for many such investigations, 29059 other medical sites across the world are running these tests."

Answered by AI

Is the trial open to any person aged thirty-five or below?

"According to the trial's eligibility criteria, only those aged 4 to 65 can participate in this study. For individuals under 18 and over 65 there are 361 and 732 trials respectively that may be better suited."

Answered by AI

How many participants have been enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this biomedical investigation is currently searching for applicants. The trial was initially launched on October 28th 2019 and has been amended as of July 16th 2022. 30 individuals must be recruited from a single site."

Answered by AI

To what conditions is Allogeneic peripheral blood stem cell therapy typically applied?

"Allogeneic peripheral blood stem cells can be utilized to address issues such as lung cancer, organ transplantation, and multiple sclerosis."

Answered by AI

Is this research actively looking for participants?

"Yes, the data on clinicaltrials.gov verifies that recruitment is currently in progress for this medical experiment. This research project was first listed on October 28th 2019 and its most recent update was made July 16th 2022. 30 participants are being sought from 1 site."

Answered by AI