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

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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.

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.

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
(414) 266-2000
Phone: 414-266-2137
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