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

Running, not enrolling · Not applicable

Conditions studied: Hematopoietic Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT00959140

Run by

University of Alabama at Birmingham

People needed

20

Starts

2014-10-01

Expected to finish

2026-12-31

Last updated by the study team

2025-12-19

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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