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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

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:
Select...
I have had a condition where my lymphocytes grow abnormally.

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
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
+6 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: 6/ RIC-SHORT ArmExperimental Treatment3 Interventions
Reduced Intensity Conditioning with shortened duration and dose-reduced PTCy
Group II: 4/ RIC-MMF ArmExperimental Treatment3 Interventions
Reduced Intensity Conditioning with MMF duration de-escalation design
Group III: 3/ MAC Arm-Closed with amendment L (07/05/2019)Experimental Treatment3 Interventions
Myeloablative Conditioning Arm
Group IV: 2/ RIC Arm - Closed with Amendment L (07/05/2019)Experimental Treatment3 Interventions
Reduced Intensity Conditioning Arm
Group V: 1/ IOC Arm-Closed with amendment L (07/05/2019)Experimental Treatment3 Interventions
Immunosuppression Only Conditioning Arm
Group VI: 5/ Donor ArmActive Control1 Intervention
Donor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GVHD Prophylaxis
2002
Completed Phase 1
~20
Reduced Intensity Conditioning
2008
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,746 Total Patients Enrolled
85 Trials studying Lymphoproliferative Disorders
67,716 Patients Enrolled for Lymphoproliferative Disorders
Dimana Dimitrova, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
177 Total Patients Enrolled
1 Trials studying Lymphoproliferative Disorders
177 Patients Enrolled for Lymphoproliferative Disorders

Media Library

Allo BMT (Allogeneic Blood or Marrow Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT02579967 — Phase 2
Lymphoproliferative Disorders Research Study Groups: 3/ MAC Arm-Closed with amendment L (07/05/2019), 5/ Donor Arm, 6/ RIC-SHORT Arm, 4/ RIC-MMF Arm, 1/ IOC Arm-Closed with amendment L (07/05/2019), 2/ RIC Arm - Closed with Amendment L (07/05/2019)
Lymphoproliferative Disorders Clinical Trial 2023: Allo BMT Highlights & Side Effects. Trial Name: NCT02579967 — Phase 2
Allo BMT (Allogeneic Blood or Marrow Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02579967 — Phase 2
~68 spots leftby Dec 2027
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