Myelodysplastic Syndrome (MDS) Clinical Trial
Official title:
CD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplant for Malignant Disease
Verified date | June 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. GVHD is a condition that results from a reaction of transplanted donor T-lymphocytes (a kind of white blood cell) against the recipient's body and organs. Study subjects will be offered treatment involving the use of the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD. This study involves subjects who are diagnosed with a malignant disease, that has either failed standard therapy or is unlikely to be cured with standard non-transplant therapy, who will receive a peripheral blood stem cell transplant. A malignant disease includes the following: Chronic Myeloid Leukemia (CML) in chronic phase, accelerated phase or blast crisis; Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS); Juvenile Myelomonocytic Leukemia (JMML); Acute Lymphoblastic Leukemia (ALL); or Lymphoma (Hodgkin's and Non-Hodgkin's).
Status | Active, not recruiting |
Enrollment | 14 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 22 Years |
Eligibility | Inclusion Criteria: General Eligibility (All Patients) - Must be < 22 years of age - Diagnosed with a malignant disease - Must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects), and must sign an informed consent - For unrelated donor: A human leukocyte antigen (HLA) 8/10, 9/10 or 10/10 matched unrelated adult donor (MUD) will be required for study entry - For related donor: A 5/10, 6/10, 7/10, 8/10, 9/10 or 10/10 matched (or partially matched) family donor will be required for study entry - Adequate renal function - Adequate liver function - Adequate cardiac function - Adequate pulmonary function Exclusion Criteria: - Patients with documented uncontrolled infection at the time of study entry are not eligible - Females who are pregnant or breast feeding at the time of study entry are not eligible |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Diane George |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of acute GVHD | Acute GVHD will be assessed and graded with standard NCI grading criteria.Evaluated daily while hospitalized, then weekly (1-60 days post-transplant), as clinically indicated (60-365 days post transplant), then 1 year, 1.5 years, 2 years and yearly (366+ days post-transplant) | Up to 2 years post-transplant | |
Secondary | Time to neutrophil engraftment | Will be assessed multiple times while hospitalized, 1-60 days post transplant, 100 days post-transplant, 180 days post-transplant, and 1-year post transplant. Neutrophil engraftment is defined as the first of three days following the neutrophil nadir with an absolute neutrophil count above 500/mm3. | Up to 1 year post-transplant | |
Secondary | Time to immune reconstitution | Immune reconstitution studies will be conducted (For T-cell, B-cell, natural killer (NK)-cell and immunoglobulins) 60 days post-transplant, 100 days post-transplant, 150 days post-transplant, 180 days post-transplant, 270 days post-transplant, 1-year post-transplant, and 2 years post transplant. | Up to 2 years post-transplant | |
Secondary | Incidence of infection complications including bacterial, viral, fungal and atypical mycobacterial and other infections | Will be assessed weekly or more as indicated until 84 or 100 days post-transplant, then as clinically indicated. | Up to 100 days post-transplant | |
Secondary | Time to platelet engraftment | Will be assessed multiple times while hospitalized, 1-60 days post transplant, 100 days post-transplant, 180 days post-transplant, and 1-year post transplant. | Up to 1 year post-transplant | |
Secondary | Incidence of chronic GVHD | Chronic GVHD will be assessed and graded with standard NCI grading criteria. | Up to 2 years post-transplant | |
Secondary | Severity of acute GVHD | Acute GVHD will be assessed and graded with standard NCI grading criteria. | Up to 2 years post-transplant | |
Secondary | Severity of chronic GVHD | Chronic GVHD will be assessed and graded with standard NCI grading criteria. Evaluated daily while hospitalized, then weekly (1-60 days post-transplant), as clinically indicated (60-365 days post transplant), then 1 year, 1.5 years, 2 | Up to 2 years post-transplant | |
Secondary | Incidence of primary graft failure | Primary graft rejection is defined as the presence of < 20% donor cells | 42 (or more) days post-transplant | |
Secondary | Incidence of secondary graft failure | The presence of < 20% donor derived hematopoietic cells in peripheral blood | 42 (or more) days post-transplant |
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