Using a special method to prepare stem cells from a close relative for transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves collecting stem cells from a close relative of patients who require a stem cell transplant but do not have a perfectly matched donor. The collected white blood cells will be treated with a CD34 antibody and separated using the CliniMACS CD34 Reagent System, an investigational device. Participants will undergo follow-up evaluations at specific intervals post-transplant to monitor their health and any potential complications. The study aims to improve outcomes for patients receiving haploidentical stem cell transplants.

Why it matters

Who can join: the full rules

Inclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)

1. Patient requiring allogeneic SCT
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent

Exclusion criteria for Stem Cell Transplant WITH Conditioning (COHORT 1)

1. Active, acute GvHD \> grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Pulmonary dysfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
4. Cardiac dysfunction (LVSF less than 25%)
5. Psychiatric disturbance
6. Lansky or Karnofsky score \< 50%
7. The presence of severe hepatic disease (direct bilirubin \>3x upper limit of normal and AST \> 5x upper limit of normal).
8. Creatinine \> 3x normal
9. Known HIV Positivity
10. Pregnancy

Inclusion Criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)

1. Allogeneic SCT Recipient requiring additional cellular therapy
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent
4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:

   1. Evidence of mixed chimerisms (less than 95% donor cells)
   2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
   3. Relapsed or persistent disease

Exclusion criteria for CD34+ Topoff WITHOUT conditioning (COHORT 2)

1. Active, acute GvHD \> grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Known HIV positivity
4. Pregnancy

Inclusion Criteria for CD34+ Topoff WITH conditioning (COHORT 3)

1. Allogeneic SCT Recipient requiring additional cellular therapy
2. Age between birth and 70 years
3. Patient and/or responsible person able to understand and sign consent
4. At least ONE of the following must be answered YES for a patient to be eligible to receive CD34+ topoff:

   1. Evidence of mixed chimerisms (less than 95% donor cells)
   2. Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
   3. Relapsed or persistent disease

Exclusion criteria for CD34+ Topoff WITH Conditioning (COHORT 3)

1. Active, acute GVHD \> grade II or extensive, chronic GvHD
2. Severe life, threatening infection
3. Pulmonary disfunction (FEV1, FVC or DLCO 40% of predicted or 3 SD below normal)
4. Cardiac dysfunction (LVSF less than 25%)
5. Psychiatric disturbance
6. Lansky or Karnofsky score \< 50%
7. The presence of severe hepatic disease (direct bilirubin \> 3x upper limit of normal and AST \> 5x upper limit of normal)
8. Creatinine \> 3x normal
9. Known HIV positivity
10. Pregnancy

Where it's running

• Houston Methodist Hospital
  Houston, Texas, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Robert Krance, MD — Baylor College of Medicine
• Study coordinator: Robert Krance, MD
• Email: rakrance@txch.org
• Phone: 832-824-4661

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Optimizing and Unifying Management of HSCT in Pediatric ALL

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• Psychosocial and behavioral support for stem cell transplant patients and their family caregivers

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  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07107165

• Improving outcomes for stem cell transplant patients using an intervention website

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• Protecting fertility in young cancer patients

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• New treatment to improve cord blood engraftment in children with leukemia after transplant

  This study is testing a new treatment to see if it can help children with leukemia have better success with cord blood transplants after their treatment.

  Recruiting Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT06155188

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.