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Clinical trials
- Participate in a clinical trial
- For medical professionals
- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - IIT-MOSKOP-MABD
Protocol Summary
- Protocol No
- IIT-MOSKOP-MABD
- Principal Investigator
- Amy Moskop
- Phase
- N/A
- Title
- Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation with Alpha/Beta T-Cell and B-Cell Depletion for Patients with Hematologic Malignancies with Targeted ATG Dosing Pilot Study, IDE 13641
- Associated Disease(s)
-
Acute Lymphoblastic Leukemia (ALL)
Acute Myelogenous Leukemia (AML)
Chronic Mylegenous Leukemia (CML)
Myeloma/Myelodysplastic Syndrome (MDS)
Other Leukemia
- Description (Summary)
- The purpose of this research study is to test a new method of cell processing for stem cell transplants with an unrelated donor or partially matched related donor. Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion. The new method is called alpha/beta T cell and B cell depletion. We want to see if this method can reduce some of the complications of the transplant and decrease the time it takes for the new stem cells to grow in the body. Donor cells will be processed with the CliniMACs device. The final product infused following the alpha/beta (T Cell) /CD19+ (B Cell) depletion is considered an investigational product.
If you have a donor that is unrelated or partially matched related, you will also receive a medication called anti-thymocyte globulin (ATG) during your conditioning. This medication will also decrease part of your immune system (T cells) which allows for engraftment and decreased risk of GVHD. This medication can increase the risk of infections, including viral and fungal infections. In addition, it can increase the risk of viral reactivation. This is when a virus that you have previously been exposed reactivates causing mild to severe symptoms of an active viral infection. There is a risk of delayed immune system recovery following your bone marrow transplant. It has been shown that optimizing the individualized dose of this medication using certain characteristics, such as your weight and lymphocyte (a type of white blood cell) count, specifically to you might decrease these risks compared to standard dosing that is same for all patients. We will use this targeted individualized dosing of ATG as part of the study which may allow us to lower the dose needed to see if we can decrease the risks described above.
The CliniMACs device is used to remove alpha/beta T cells that may cause graft vs. host disease (GVHD) and B cells that carry Epstein-Barr virus. You are eligible because you have an eligible donor, and your risk of GVHD is extremely high. We think that elimination of the alpha/beta T cells using CliniMACs, an investigational device, may decrease the risk of GVHD.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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