← Back to Search

Monoclonal Antibodies

Stem Cell Transplant for Immune Deficiency Syndrome

Phase 2
Recruiting
Led By Dennis D Hickstein, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Availability of an 8/8, 7/8, or 6/8 HLA-matched related or unrelated donor, or a haploidentical related donor
Age >= 4 years and <=69 years with Weight >=12 kilograms
Must not have
HIV-positive patients
Patients with known brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up +180 and 1 year post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether stem cell transplants can be used to treat people with primary immunodeficiency diseases.

Who is the study for?
This trial is for people aged 4-69 with primary immunodeficiency diseases who haven't responded to standard treatments or have no other options. Participants need functioning major organs, a matched donor, and must agree to use contraception. Excluded are those with brain metastases, HIV, severe allergies to study drugs, uncontrolled illnesses, certain psychiatric conditions, pregnant or breastfeeding women.
What is being tested?
The trial tests if stem cell transplants can cure primary immunodeficiencies. It involves screening donors and recipients; pre-transplant exams; hospitalization for the transplant procedure including medications through a catheter; post-transplant monitoring with regular visits up to five years.
What are the potential side effects?
Potential side effects include reactions related to immune suppression such as increased infection risk from Alemtuzumab and Tacrolimus. Total body irradiation may cause fatigue and nausea. Mycophenolate mofetil could lead to digestive issues while Cyclophosphamide might result in hair loss or bladder irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a donor who is a close match to my tissue type.
Select...
I am between 4 and 69 years old and weigh at least 12 kilograms.
Select...
I have a genetic mutation identified by a certified lab and standard treatments haven't worked for me.
Select...
My heart, kidneys, liver, and lungs are functioning within normal ranges.
Select...
I can do most activities but need help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am HIV-positive.
Select...
I have brain metastases.
Select...
I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~+180 and 1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and +180 and 1 year 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
Sustained donor engraftment
Secondary study objectives
Event free survival
Disease
Incidence of Chronic Graft-versus-host disease
+5 more

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Arm AActive Control8 Interventions
Low Intensity, Intermediate Intensity and High Intensity Conditioning with or without alemtuzumab
Group II: Arm BActive Control9 Interventions
Intermediate Intensity Conditioning with or without Alemtuzumab

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,514 Total Patients Enrolled
Dennis D Hickstein, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
224 Total Patients Enrolled
Sung-Yun Pai, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Alemtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04339777 — Phase 2
Lymphoproliferative Disorder Research Study Groups: Arm A, Arm B
Lymphoproliferative Disorder Clinical Trial 2023: Alemtuzumab Highlights & Side Effects. Trial Name: NCT04339777 — Phase 2
Alemtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339777 — Phase 2
~19 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top