Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors

NCT00959140 | Active Not Recruiting DMC FDA Device

• 1 other identifier: UAB 1410
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). As well as to help discover if dose standardization causes less variation in outcomes between patients and to make transplantation more predictable and complications easier to manage.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Allo PBSC; HSCT; Bone Marrow Transplant; Allogeneic Bone Marrow Transplant; Matched Related Donor Transplant; MRD HSCT

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of acute graft versus host disease (aGVHD) with the chosen fixed dose of CD3+ cells

  1 year

Secondary Outcomes (6)

• Time to engraftment

  60 days

• State of chimerism over time

  2 years

• Immune reconstitution over time

  2 years

• Incidence, severity and organ involvement with chronic GVHD (cGVHD)

  2 years

• Overall survival

  2 years

Study Arms (1)

CD3+ T-cell depletion

EXPERIMENTAL

CD3+ T-cell depletion

Device: CD3+ T cell depletion

Interventions

CD3+ T cell depletion DEVICE

The peripheral blood stem cell product is engineered to deliver a dose of 15 to 20 x10\^7 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation. Following collection, CD3+ T cells will be enumerated and a portion of the product containing 15 to 20 x10\^7 CD 3+ cells/kg will be set aside. The remainder of the product will be depleted of CD3+ T cells. Following CD3+ T cell depletion, the CD3+ T cell depleted product will then be combined with the unmanipulated product to provide the specified levels of CD3+ T cells/kg recipient body-weight. The graft is infused into the patient on the same day as selected and within 24 hours of donor aphaeresis.

CD3+ T-cell depletion

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥19 years of age.
• Patients must meet all the UAB diagnosis and disease status criteria for clinical appropriateness for myeloablative allo HSCT derived from ASBMT and NCCN guidelines.
• Patients must have a 10/10 HLA matched sibling (excluding identical twin). All donors will be evaluated for eligibility and suitability per standard of care according FACT and NMDP guidelines.
• Adequate organ function: All organ function testing should be done within 28 days of study registration.
• Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
• Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted.
• Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula
• Performance status: Karnofsky ≥ 70%
• Hepatic (values to be less than what is considered grade II toxicity per the CTCAE (common terminology criteria for adverse events)

You may not qualify if:

• Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration.
• HIV positive patients.
• Prior autologous or allogeneic transplantation for any disease.
• Scheduled to receive non-myeloablative or reduced intensity conditioning regimen.
• High Risk Features associated with increased relapse risk or poor outcomes:
• AML/ALL: with Bi-phenotypic features
• AML: Refractory to Induction and salvage therapy
• ALL: Refractory to Induction and salvage therapy
• CML: Active blast crisis
• HL: Disease refractory to chemotherapy or targeted therapy
• NHL: Disease refractory to chemotherapy or targeted therapy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Miltenyi Biotec, Inc.: collaborator

Study Sites (1)

University of Alabama Hospital

Birmingham, Alabama, 35294, United States

Location

Related Links

• BMTCT Program Web Site

Study Officials

• Ayman Saad, MD

  University of Alabama in Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 14, 2009
• Study Start: October 1, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)