Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 4 Weeks to 75

Infusion of selected stem cells to improve graft function in blood cancer patients

Official title: Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS

Run by University of Alabama at Birmingham · NCT06047886 · Data updated 2026-11-12

This study is testing if infusing special stem cells can help blood cancer patients who have had problems with their stem cell transplant feel better and avoid complications.

More Myelodysplastic Syndromes trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages4 Weeks to 75 Years
SexAll
Enrollment50 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedApril 22, 2025
Main results expectedOctober 2029
Study endsDecember 2029
Registry record updatedApril 13, 2026
Trial IDNCT06047886 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who have undergone allogeneic hematopoietic stem cell transplantation and are experiencing graft failure or low graft function.

Probably not a fit

Patients who are non-compliant, have uncontrolled medical or psychiatric disorders, or are pregnant or breastfeeding may not benefit from this study.

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

What this trial studies

This clinical trial focuses on patients who have experienced graft failure or delayed engraftment following allogeneic hematopoietic stem cell transplantation for hematologic malignancies. The study aims to evaluate the safety and efficacy of infusing CD34 selected hematopoietic stem cells using the automated CliniMACS Prodigy system, which streamlines the processing of stem cells. By avoiding standard immune suppression strategies, the trial seeks to reduce the risk of graft versus host disease in these patients. Eligible participants include those with acute myeloid leukemia, acute lymphoblastic leukemia, lymphoid malignancies, myelodysplastic syndromes, and chronic myeloid leukemia who require a stem cell boost.

Why it matters

Potential benefit: If successful, this approach could significantly improve graft function and reduce complications for patients with hematologic malignancies.

How similar studies have gone: Previous studies using CD34 selected grafts have shown safety and efficacy, indicating a promising approach in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
4. Myelodysplastic syndromes with \<=10% blasts
5. CML in morphologic remission after blast phase or accelerated phase
6. Primary myelofibrosis with \<=10% blasts \^morphologic remission is defined as \<5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.

Exclusion Criteria:

1. Non-compliant patients.
2. No appropriate caregivers identified.
3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
4. Patients with known allergy to DMSO.
5. Pregnant or breastfeeding women

Where it's running

  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.