Infusion of selected stem cells to improve graft function in blood cancer patients
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Weeks to 75 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06047886 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone allogeneic hematopoietic stem cell transplantation and are experiencing graft failure or low graft function.
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.
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 performed: Previous studies using CD34 selected grafts have shown safety and efficacy, indicating a promising approach in this area.
Eligibility criteria
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 this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Antonio Di Stasi, M.D.
- Email: adistasi@uab.edu
- Phone: 205-934-2636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.