Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Phase 2Active Not RecruitingNCT02323867

Children's Hospital of Philadelphia140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Leukemia Lymphoma Myelodysplasia

Interventions

Eligibility

Sex: ALLMax age: 23 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days

Time frame: 1 year

Secondary Outcomes

Severe acute and chronic graft versus host disease (GVHD)

Estimation of the incidence and extent of acute and chronic GVHD. The overall incidence of acute GVHD, the incidence of Grade 4 acute GVHD and the incidence of chronic GVHD.