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

UNRELATED AND PARTIALLY MATCHED RELATED DONOR PERIPHERAL STEM CELL TRANSPLANTATION WITH Alpha/Beta T CELL AND B CELL DEPLETION FOR PATIENTS WITH HEMATOLOGIC MALIGNANCIES

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02323867

Acronym

AB-CliniMACs

Enrollment

140

Registered

2014-12-24

Start date

2014-10-31

Completion date

2027-10-31

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma, Myelodysplasia

Keywords

Transplant, Alternative Donor

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.

Interventions

DEVICEAlpha Beta T cell depletion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

intervention with device: Alpha Beta T cell depletion

Eligibility

Sex/Gender

ALL

Age

No minimum to 23 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Engraftment: rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days	1 year

Secondary

Measure	Time frame	Description
Severe acute and chronic graft versus host disease (GVHD)	1 year	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026