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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up +180 and 1 year post transplant

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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 outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,387 Total Patients Enrolled

85 Trials studying Lymphoproliferative Disorders

67,728 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: 6/ RIC-SHORT Arm, 3/ MAC Arm-Closed with amendment L (07/05/2019), 5/ Donor 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

Frequently Asked Questions

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

Who meets the requirements to be a test subject in this clinical trial?

"This study is looking for patients that currently have lymphoproliferative disorders, are between the ages of 4 and 75, and meet the following criteria: Patients age greater than or equal to 4 through 75 years, Patients without a mutation must be deemed eligible and appropriate for allo BMT by the PI. Some patients may meet the clinical history criteria listed below, but will not be eligible if it is thought that their clinical history is due to a condition apart from an immune defect. In addition, patients with a PID of mild severity, such as those with selective IgA deficiency, may meet at least two of the clinical history"

Answered by AI

Are new participants being taken in for this research project?

"That is correct. The online information regarding this clinical trial indicates that it is open for enrollment and looking for patients. This particular trial was first posted on 19th November 2015, with the most recent update being on 1st November 2022. There are a total of 224 positions available at 3 different locations."

Answered by AI

What does the FDA think of Allo BMT as a treatment option?

"While Phase 2 trials offer less evidence of safety than Phase 3, our team still gave Allo BMT a score of 2."

Answered by AI

What do researchers hope to discover or prove with this experiment?

"The purpose of this study, which will take place over a period of 180 days or more after allogeneic bone marrow transplantation, is to determine the shortest duration of MMF that can be safely administered without an increased risk of graft failure or acute grade 3-4 GVHD. Secondary outcomes include event-free survival (time from transplant to death or other events such as disease relapse, graft failure, grade 3-4 acute GVHD, chronic GVHD requiring systemic therapy, or receipt of post-transplant donor cell infusion), transplant-related mortality (cumulative incidence of transplant-related mortality at 180 days and 1"

Answered by AI