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Allogeneic Blood or Marrow Transplantation

Bone Marrow Transplant for Immune Deficiency

Phase 2

Recruiting

Led By Dimana Dimitrova, 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

Patients age greater than or equal to 4 through 75 years

Availability of at least one 7-8/8 (9-10/10) HLA-matched related or unrelated donor, or an HLA-haploidentical related donor

Must not have

History of any lymphoproliferative disorder

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 allogeneic blood or marrow transplant is safe and effective in treating people with primary immunodeficiencies.

Who is the study for?

This trial is for people aged 4-75 with primary immunodeficiencies that could be treated by a blood or marrow transplant. Donors must be healthy and at least 4 years old. Participants need to have certain immune system issues, like severe infections or autoimmune diseases, and good organ function. Pregnant women can't join, and participants must agree to use contraception for one year post-transplant.

What is being tested?

The trial tests if blood or bone marrow transplants from donors are safe and effective in treating various primary immunodeficiencies. It involves screening, pre-transplant assessments, chemotherapy before the transplant day, hospital stay for several weeks with follow-up visits up to five years.

What are the potential side effects?

Potential side effects include reactions to anesthesia during bone marrow harvests; complications from stem cell collection; risks associated with chemotherapy such as nausea, hair loss, fatigue; infection risk due to weakened immunity; graft-versus-host disease where donor cells attack recipient's body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between the ages of 4 and 75.

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I have a donor who is a close match to my tissue type.

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My cancer is currently in remission.

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I have a severe primary immunodeficiency that qualifies for a bone marrow transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes grow abnormally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ +180 and 1 year post transplant

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

For the RIC : To estimate the aGVHD-free, graft failure-free survival

For the RIC-MMF arm: To determine the shortest duration of MMF that can be safely administered without excessive rates of graft failure or acute grade 3-4 GVHD

For the RIC-SHORT arm: To estimate the aGVHD-free, graft failure-free survival

Secondary study objectives

Disease free survival

Event-free survival

Incidence of Acute Graft-versus-host disease

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