Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02323867

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplasia Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

Up to 23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who do not meet disease, organ or infectious criteria.
  • No suitable donor
  • 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.

Treatment and study plan

Alpha Beta T cell depletion

Device

Primary outcomes

  1. 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

  1. Severe acute and chronic graft versus host disease (GVHD)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study 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

Acronym: AB-CliniMACs

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2014
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.