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Stem Cell Transplant

Unrelated donor transplantation for Aplastic Anemia (BMT CTN CureAA Trial)

Phase 2
Waitlist Available
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age 3 years to 75 years
a. Bone marrow cellularity \< 25% or variable marrow cellularity but with \< 30% residual hematopoietic cells deemed HYPOcellular for age AND b. Two (2) out of 3 of the following (in peripheral blood). i. Neutrophils \< 0.5 x109/L ii. Platelets \< 20 x109/L iii. Reticulocyte count \< 20 x109/L (\< 60 x 109/L using an automated analysis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-hsct
Awards & highlights

Summary

BMT CTN 2207 will investigate the use of marrow transplantation for treatment of severe aplastic anemia that has not previously been treated.

Who is the study for?
This trial is for individuals with severe aplastic anemia who haven't been treated before. It's open to those eligible for bone marrow transplants from half-matched (haploidentical) or completely unrelated donors.
What is being tested?
The study compares two types of bone marrow transplants in treating severe aplastic anemia: one from a half-matched family member and another from a non-related donor.
What are the potential side effects?
Bone marrow transplant side effects can include infection risk, graft-versus-host disease, bleeding complications, organ damage, and reactions to the new marrow.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-hsct
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-hsct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Graft versus host disease (GVHD)-free failure-free survival (GFFS) at One year
Secondary study objectives
Participants Alive and Engrafted at One year post conditioning
Participants with Hematologic Response post-transplant
Percentage of Participants with Failure-Free Survival (FFS) at One year post conditioning
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Unrelated donor transplantationActive Control1 Intervention
Patients receiving bone marrow transplanted from an unrelated donor will be included in this arm.
Group II: Haploidentical transplantationActive Control1 Intervention
Patients receiving bone marrow transplanted from a haploidentical related donor will be included in this arm.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,876 Previous Clinical Trials
47,825,080 Total Patients Enrolled
11 Trials studying Aplastic Anemia
922 Patients Enrolled for Aplastic Anemia
SanofiIndustry Sponsor
2,183 Previous Clinical Trials
3,978,397 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
618 Previous Clinical Trials
1,163,349 Total Patients Enrolled
~40 spots leftby Aug 2028
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