UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial, called UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy, is exploring a new treatment option for patients with specific types of blood cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and other blood disorders. The focus is on patients who have experienced graft failure or delayed recovery after a stem cell transplant. The trial aims to provide a special type of stem cell infusion, selected using a machine called the CliniMACS Prodigy, which may reduce the risk of complications like graft versus host disease, where the donor cells attack the recipient’s body.

To be eligible for this trial, patients should have certain conditions like AML or ALL in remission but with high-risk features, or other specific blood disorders with a limited number of immature cells in their bone marrow. Participants will undergo a procedure that involves the infusion of these specially selected stem cells, and the trial is currently recruiting individuals aged from 28 years up to 27393 years, with no restrictions based on gender. It's important to know that individuals with certain medical conditions, those not able to follow instructions, or pregnant and breastfeeding women may not be eligible to participate. Overall, this trial is about finding safer and more effective ways to help patients recover after serious blood-related illnesses.

Gender

ALL

Eligibility 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