Cord Blood Transplant for Blood Cancers and Diseases

Phase 1 & 2

Recruiting

Led By Richard W Childs, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

Must not have

Patients who are receiving only licensed CBUs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people who need cord blood transplants and best match cord blood units that are not FDA-licensed. Doctors will observe participants for up to a year after the transplant.

Who is the study for?

This trial is for pediatric and adult patients of any age with blood cancers or diseases affecting the bone marrow, like Myelodysplastic Syndrome or Aplastic Anemia. Participants must need a cord blood transplant and match with unlicensed cord blood units that meet NMDP standards but not current FDA standards.

What is being tested?

The study is testing the use of unlicensed preserved cord blood units for transplants in individuals who require them. These cord blood units comply with National Marrow Donor Program standards but may fall short of newer FDA requirements.

What are the potential side effects?

While specific side effects are not listed, potential risks generally associated with cord blood transplants include infection, graft-versus-host disease, bleeding complications, and reactions to infused cells.

Eligibility Criteria

Inclusion Criteria

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

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I have a blood disorder that is inherited, acquired, or caused by treatment.

Exclusion Criteria

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

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I am only receiving treatments approved by health authorities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after unlicensed CBU transplant.

Secondary study objectives

Assess incidence of graft rejection, transmission of infection, serious infusion reactions. Determine 1 year survival. Assess cumulative incidence of acute GVHD (grades II to IV), (grades III to IV), and incidence of chronic GVHD.