Back to resultsCD34 Selection Using the Automated CliniMACS Prodigy
Primary Purpose
AML, ALL, Lymphoid Malignancies
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Infusion of CD34 selected hematopoietic stem cells
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring hematologic malignancies, graft failure
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment population
Arm Description
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.
Outcomes
Primary Outcome Measures
Severe acute GVHD
Incidence of severe (grade III-IV) acute GVHD <=25% at 100 days
extensive chronic GVHD
Incidence of extensive chronic GVHD <=10% at one year.
donor chimerism
Improvement of donor chimerism by >=15%
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
Secondary Outcome Measures
Non-relapse mortality
Rate of one-year non-relapse mortality (NRM).
Disease relapse
Rate of one-year relapse
overall survival
Rate of one-year overall survival (OS).
Absolute neutrophil count
ANC engraftment or increase
Full Information
NCT ID
NCT06047886
First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT06047886
Brief Title
CD34 Selection Using the Automated CliniMACS Prodigy
Official Title
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, ALL, Lymphoid Malignancies, Myelodysplastic Syndromes, CML, Primary Myelofibrosis
Keywords
hematologic malignancies, graft failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study of CD34 selection for graft versus host disease (GVHD) Prophylaxis using the automated CliniMACS Prodigy Device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment population
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Infusion of CD34 selected hematopoietic stem cells
Intervention Description
CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion
Primary Outcome Measure Information:
Title
Severe acute GVHD
Description
Incidence of severe (grade III-IV) acute GVHD <=25% at 100 days
Time Frame
6 years
Title
extensive chronic GVHD
Description
Incidence of extensive chronic GVHD <=10% at one year.
Time Frame
6 years
Title
donor chimerism
Description
Improvement of donor chimerism by >=15%
Time Frame
6 years
Title
Clinical improvement
Description
Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Non-relapse mortality
Description
Rate of one-year non-relapse mortality (NRM).
Time Frame
6 years
Title
Disease relapse
Description
Rate of one-year relapse
Time Frame
6 years
Title
overall survival
Description
Rate of one-year overall survival (OS).
Time Frame
6 years
Title
Absolute neutrophil count
Description
ANC engraftment or increase
Time Frame
6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Di Stasi, M.D.
Phone
205-934-2636
Email
adistasi@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chowdury Nazma
Email
nazma@uab.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24156789
Citation
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.
Results Reference
background
PubMed Identifier
22869882
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.
Results Reference
background
PubMed Identifier
34595425
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.
Results Reference
background
PubMed Identifier
25981397
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.
Results Reference
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CD34 Selection Using the Automated CliniMACS Prodigy
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