UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

NCT06047886 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IDE29384
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

Conditions

ALL; Lymphoid Malignancies; Myelodysplastic Syndromes; CML; Primary Myelofibrosis; AML

Keywords

hematologic malignancies; graft failure

Outcome Measures

Primary Outcomes (4)

• Severe acute GVHD

  Incidence of severe (grade III-IV) acute GVHD \<=25% at 100 days

  6 years

• extensive chronic GVHD

  Incidence of extensive chronic GVHD \<=10% at one year.

  6 years

• donor chimerism

  Improvement of donor chimerism by \>=15%

  6 years

• Clinical improvement

  Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes

  6 years

Secondary Outcomes (4)

• Non-relapse mortality

  6 years

• Disease relapse

  6 years

• overall survival

  6 years

• Absolute neutrophil count

  6 years

Study Arms (1)

Treatment population

EXPERIMENTAL

Patients status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function will receive a CD34 selected hematopoietic stem cell infusion with or without preceding conditioning. Fludarabine 25 mg/mq day 1 - 5 + 2 Gray Total body irradiation depending on clinician's discretion (with the addition of cyclophosphamide 14.5 mg/kg for two doses for haploidentical or matched unrelated donor with at least one major HLA mismatch). Recommendation to use a conditioning regimen include complete loss of donor chimerism, trilineage cytopenias.

Drug: Infusion of CD34 selected hematopoietic stem cells

Interventions

Infusion of CD34 selected hematopoietic stem cells DRUG

CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Treatment population

Eligibility Criteria

• Age: 4 Weeks - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
• ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
• Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
• Myelodysplastic syndromes with \<=10% blasts
• CML in morphologic remission after blast phase or accelerated phase
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

RECRUITING

Related Publications (4)

• Locatelli F, Lucarelli B, Merli P. Current and future approaches to treat graft failure after allogeneic hematopoietic stem cell transplantation. Expert Opin Pharmacother. 2014 Jan;15(1):23-36. doi: 10.1517/14656566.2014.852537. Epub 2013 Oct 25.

  PMID: 24156789 BACKGROUND

• Pasquini MC, Devine S, Mendizabal A, Baden LR, Wingard JR, Lazarus HM, Appelbaum FR, Keever-Taylor CA, Horowitz MM, Carter S, O'Reilly RJ, Soiffer RJ. Comparative outcomes of donor graft CD34+ selection and immune suppressive therapy as graft-versus-host disease prophylaxis for patients with acute myeloid leukemia in complete remission undergoing HLA-matched sibling allogeneic hematopoietic cell transplantation. J Clin Oncol. 2012 Sep 10;30(26):3194-201. doi: 10.1200/JCO.2012.41.7071. Epub 2012 Aug 6.

  PMID: 22869882 BACKGROUND

• Roldan E, Perales MA, Barba P. Allogeneic Stem Cell Transplantation with CD34+ Cell Selection. Clin Hematol Int. 2019 Sep 1;1(3):154-160. doi: 10.2991/chi.d.190613.001. eCollection 2019 Sep.

  PMID: 34595425 BACKGROUND

• Spohn G, Wiercinska E, Karpova D, Bunos M, Hummer C, Wingenfeld E, Sorg N, Poppe C, Huppert V, Stuth J, Reck K, Essl M, Seifried E, Bonig H. Automated CD34+ cell isolation of peripheral blood stem cell apheresis product. Cytotherapy. 2015 Oct;17(10):1465-71. doi: 10.1016/j.jcyt.2015.04.005. Epub 2015 May 14.

  PMID: 25981397 BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes; Primary Myelofibrosis; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Neoplasms by Site; Neoplasms

Central Study Contacts

Antonio Di Stasi, M.D.

CONTACT

205-934-2636; adistasi@uab.edu

Chowdury Nazma

CONTACT

nazma@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility study of CD34 selection for graft versus host disease (GVHD) Prophylaxis using the automated CliniMACS Prodigy Device.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: April 22, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)