UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-75
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Infusion of CD34 selected hematopoietic stem cells
DrugCD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Treatment populationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Severe acute GVHD
Incidence of severe (grade III-IV) acute GVHD \<=25% at 100 days
Time frame
6 years2
extensive chronic GVHD
Incidence of extensive chronic GVHD \<=10% at one year.
Time frame
6 years3
donor chimerism
Improvement of donor chimerism by \>=15%
Time frame
6 years4
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
Time frame
6 yearsSecondary outcomes
1
Non-relapse mortality
Rate of one-year non-relapse mortality (NRM).
Time frame
6 years2
Disease relapse
Rate of one-year relapse
Time frame
6 years3
overall survival
Rate of one-year overall survival (OS).
Time frame
6 years4
Absolute neutrophil count
ANC engraftment or increase
Time frame
6 yearsSponsors and contacts
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Source ClinicalTrials.gov