Status:
ACTIVE_NOT_RECRUITING
Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Miltenyi Biotec, Inc.
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
19+ years
Phase:
NA
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 do...
Detailed Description
The optimal CD3+ cell dose to be used for allo HSCT is unknown. In addition, there are multiple variables in addition to CD3+ cell dose which affect engraftment, immune reconstitution, GVH and GVL in ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
- Exclusion criteria
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00959140
Start Date
October 1 2014
End Date
December 31 2026
Last Update
December 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama Hospital
Birmingham, Alabama, United States, 35294