Clinical trial NCT02600208: Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies with Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hematologic Malignancies
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Miltenyi Biotec, Inc.
First posted: 2015-11-09
Enrollment: 60
Sex: FEMALE
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
timeFrame: DAY 42
Secondary outcomes:
measure: Assess the probability of one year leukemia free survival (LFS).
timeFrame: 1 year
measure: Estimate the incidence and extent of acute and chronic graft vs. host disease.
timeFrame: 1 year
measure: Assess the incidence treatment-related mortality (TRM).
timeFrame: 1 year
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Julie-An Talano, MD
role: PRINCIPAL_INVESTIGATOR
References: