CD34 Selection Using the Automated CliniMACS Prodigy

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06047886
• Other study ID #: IDE29384
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: December 2029

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: Antonio Di Stasi, M.D.
• Phone: 205-934-2636
• Email: adistasi[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients eligible to be treated on this status are 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 (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2029
• Est. primary completion date: October 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Weeks to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• ALL
• AML
• CML
• Lymphoid Malignancies
• Myelodysplastic Syndromes
• Neoplasms
• Primary Myelofibrosis

Intervention

Drug:
• Infusion of CD34 selected hematopoietic stem cells
CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe acute GVHD	Incidence of severe (grade III-IV) acute GVHD <=25% at 100 days	6 years
Primary	extensive chronic GVHD	Incidence of extensive chronic GVHD <=10% at one year.	6 years
Primary	donor chimerism	Improvement of donor chimerism by >=15%	6 years
Primary	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	Non-relapse mortality	Rate of one-year non-relapse mortality (NRM).	6 years
Secondary	Disease relapse	Rate of one-year relapse	6 years
Secondary	overall survival	Rate of one-year overall survival (OS).	6 years
Secondary	Absolute neutrophil count	ANC engraftment or increase	6 years