Status:
TERMINATED
T-cell Receptor α/β Depleted Donor Lymphocyte Infusion
Lead Sponsor:
Guenther Koehne
Conditions:
Lymphoid Leukemia, Acute
Myeloid Malignancy
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell trans...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation.
- Patients must have a Karnofsky (adult) Performance Status of at least 70%.
- Patients must have adequate organ function measured by:
- Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise.
- Hepatic: \< 3x upper limit of normal (ULN) AST and \< 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders).
- Renal: serum creatinine: ≤ 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 40 mL/min (measured or calculated/estimated).
- Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin).
- Each patient must be willing to participate as a research subject and must sign an informed consent form.
Exclusion
- Patients with active acute GvHD.
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05350163
Start Date
April 5 2022
End Date
September 18 2023
Last Update
December 10 2024
Active Locations (1)
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1
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States, 33176