UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Phase 1RecruitingNCT06047886

University of Alabama at Birmingham50 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Severe acute GVHD

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

Time frame: 6 years

extensive chronic GVHD

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

Time frame: 6 years

donor chimerism

Improvement of donor chimerism by \>=15%

Time frame: 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

Time frame: 6 years

Secondary Outcomes

Non-relapse mortality

Rate of one-year non-relapse mortality (NRM).

Time frame: 6 years

Disease relapse

Rate of one-year relapse

Time frame: 6 years

overall survival

Rate of one-year overall survival (OS).

Time frame: 6 years

Absolute neutrophil count

ANC engraftment or increase

Time frame: 6 years

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts