Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 23 |
Updated: | 6/3/2018 |
Start Date: | October 2015 |
End Date: | December 2022 |
Contact: | Adam Fiebelkorn |
Email: | afiebelk@mcw.edu |
Phone: | 414-266-2137 |
BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha Beta T Cell and B Cell Depletion For Patients With Hematologic Malignancies
This is a single arm pilot study for patients with hematologic malignancies with alternative
donor sources receiving unrelated or partially matched related/Haploidentical mobilized
peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus
CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one
year leukemia free survival.
donor sources receiving unrelated or partially matched related/Haploidentical mobilized
peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus
CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one
year leukemia free survival.
The purpose of this research study is to evaluate a new method of T cell depletion using the
Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant
utilizing either a unrelated donor or partially matched/haploidentical related donor. This
new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot
study will evaluate if this new method of T cell and B cell depletion is a more effective way
of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a
durable engraftment.
Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant
utilizing either a unrelated donor or partially matched/haploidentical related donor. This
new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot
study will evaluate if this new method of T cell and B cell depletion is a more effective way
of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a
durable engraftment.
Inclusion Criteria:
Patient:
1. Age. Patient age < 23 years. Both genders and all races eligible.
2. Disease eligibility
Leukemias/lymphomas:
- Acute myeloid leukemia, primary or secondary
- Disease status: remission or <10% bone marrow blasts
- Myelodysplasia
- Acute lymphoblastic leukemia
- Disease status: in hematologic remission
- Chronic myelogenous leukemia:
- Disease status: chronic phase, accelerated phase or blast crisis now in second chronic
phase.
- Mixed lineage or biphenotypic acute leukemia
- Lymphoblastic lymphoma
- Disease status: remission
- Burkitt's lymphoma/leukemia:
- Disease status: in remission
Exclusion Criteria:
- Patient
1. Patients who do not meet disease, organ or infectious criteria.
2. No suitable donor
We found this trial at
1
site
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Phone: 414-266-2137
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