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AB-CliniMACs: Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Recruiting
CT.gov ID
NCT02323867
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
132
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Alpha Beta T cell depletion
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
intervention with device: Alpha Beta T cell depletionintervention with device: Alpha Beta T cell depletion
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alpha Beta Total Body Irradiation - total body irradiation (TBI) first

Alpha Beta Total Body Irradiation - TBI first Day Treatment 11 Anti-thymocyte globulin (ATG) 10 ATG 9 ATG 8 TBI 7 TBI 6 TBI 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 Rest 0 Transplant with alpha beta T cell depleted stem cells

Device: Alpha Beta T cell depletion
Experimental: Alpha Beta Total Body Irradiation - TBI last

Alpha Beta Total Body Irradiation - TBI last Day Treatment 9 ATG 8 ATG 7 Thiotepa + ATG 6 Thiotepa 5 Cyclophosphamide 4 Cyclophosphamide 3 TBI 2 TBI 1 TBI 0 Transplant with alpha beta T cell depleted stem cells

Device: Alpha Beta T cell depletion
Experimental: Alpha Beta Non-irradiation regimen

Alpha Beta Non-irradiation regimen Day Treatment 9 Busulfan + ATG 8 Busulfan + ATG 7 Busulfan +ATG 6 Busulfan 5 Thiotepa 4 Thiotepa 3 Cyclophosphamide 2 Cyclophosphamide 1 0 Transplant with alpha beta T cell depleted stem cells

Device: Alpha Beta T cell depletion

Outcome Measures

Primary Outcome Measures

  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 [1 year]

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 23 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Acceptable organ status clearance

  2. No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic

  3. Signed informed consent.

  4. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19103

Sponsors and Collaborators

  • Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Nancy J Bunin, MD, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nancy Bunin, Director, Blood and Marrow Transplant, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT02323867
Other Study ID Numbers:
  • 13-010495
  • BT13BTθ51
First Posted:
Dec 24, 2014
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Nancy Bunin, Director, Blood and Marrow Transplant, Children's Hospital of Philadelphia
Transplant
Alternative Donor
Additional relevant MeSH terms:
Hematologic Neoplasms
Preleukemia
Myelodysplastic Syndromes

Study Results

No Results Posted as of Nov 3, 2021