Clinical trial NCT02323867: Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies
Official title: 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
Conditions: Leukemia
Lymphoma
Myelodysplasia
Keywords: Transplant
Alternative Donor
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 140
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: intervention with device: Alpha Beta T cell depletion
Primary purpose: TREATMENT

Brief summary: This is a single arm pilot study for patients using α/β T cell-depleted peripheral Stem Cell Transplantation (PSCT) in with alternative donor sources with hematologic malignancies receiving alternative donor (unrelated or partially matched related) mobilized peripheral stem cells (PSCs) using the CliniMACS system for T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and graft versus host disease (GVHD), and one year leukemia free survival.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Acceptable organ status clearance
3. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic
4. Signed informed consent.
5. Negative pregnancy test for females of childbearing potential.

Exclusion Criteria:

1. Patients who do not meet disease, organ or infectious criteria.
2. No suitable donor
3. Received previous allogeneic transplant

Donor must be either unrelated, mismatched up to one antigen/one antigen and one allele or a related, HLA match other than a sibling.

Primary outcomes:
measure: Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
timeFrame: 1 year
Secondary outcomes:
measure: Severe acute and chronic graft versus host disease (GVHD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Timothy Olson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leahy AB, Li Y, Talano JA, Elgarten CW, Seif AE, Wang Y, Johnson B, Monos DS, Kadauke S, Olson TS, Freedman J, Wray L, Grupp SA, Bunin N. Unrelated donor alpha/beta T cell- and B cell-depleted HSCT for the treatment of pediatric acute leukemia. Blood Adv. 2022 Feb 22;6(4):1175-1185. doi: 10.1182/bloodadvances.2021005492.