Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT02424968
Eligibility Criteria:
Inclusion Criteria:
* Must have a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor
* Must have a myeloid or lymphoid malignant disease that is treated with TLI and ATG reduced intensity conditioning for allogeneic transplant (any of the following AML, myelodysplastic syndrome \[MDS\], myeloproliferative disease \[MPD\], CLL, B or T-cell NHL, HL)
* Patients who due to age, pre-existing medical conditions, or, prior therapy are considered to be at high risk for regimen related toxicity associated with fully ablative transplant conditioning, and therefore reduced intensity conditioning is recommended
* Ability to understand and the willingness to sign a written informed consent document; patients must have signed informed consent to participate in the trial
* DONOR: Must be an HLA-matched or single allele mismatched sibling of enrolled transplant patient
* DONOR: Must be 18-75 years of age, inclusive
* DONOR: Must be in a state of general good health and have completed a donor evaluation with history, medical examination and standard blood tests within 35 days of starting the hematopoietic cell collection procedure; in order to fairly represent the interests of the donor, the donor evaluation and consent will be performed by a study team member other than the recipient's attending physician
* DONOR: Must have a white blood cell count \> 3.5 x 10\^9/liter, platelets \> 150 x 10\^9/liter and hematocrit \> 35%
* DONOR: Must be capable of undergoing leukapheresis
* DONOR: Must be able to understand and sign informed consent
* DONOR: Must not be seropositive for HIV 1 and 2, hepatitis B surface antigen, hepatitis C antibody, human T-lymphotropic virus (HTLV) antibody, cytomegalovirus (CMV) immunoglobulin M (IgM), or rapid plasma reagin (RPR) (Treponema); donors with prior evidence of hepatitis B core antibody positivity will have a polymerase chain reaction (PCR) test done to evaluate for hepatitis B infection; donors with a positive hepatitis B PCR test are excluded
* DONOR: Females must not be pregnant or lactating
* DONOR: Must not have psychological traits or psychological or medical conditions which make them unlikely to tolerate the procedure
* DONOR: Must not have developed a new malignancy requiring chemotherapy or radiation in the interval since apheresis for initial hematocrit (HCT)
* PATIENT CRITERIA FOR PROCEEDING WITH CD8+ MEMORY T-CELL INFUSION:
* Patients must be beyond day 30 and before day 60 after transplant
* Patients must have evidence of mixed CD3 T-cell chimerism based on the day +28 (+/- 7 days) blood sample showing \>= 5% and =\< 95% donor type cells
* Patients must have no evidence of active graft-versus-host disease at the time of the CD8+ memory T-cell infusion; patients with a history of acute GVHD overall grade II based on skin only involvement or upper gastrointestinal (GI) tract involvement only will be eligible; patients with a history of liver or lower GI tract GVHD will not be eligible
* Patients must be on single immune suppression therapy with either tacrolimus or cyclosporine at the time of CD8+ memory T-cell infusion; prednisone at a physiologic dose of 5 mg per day or less is allowed
* Patients must have a Karnofsky performance status of \>= 60% at the time of the CD8+ memory T-cell infusion
* Patients must not have an uncontrolled bacterial, fungal or viral infection, defined as progressive symptoms despite therapy, at the time of the CD8+ memory T-cell infusion; asymptomatic viremia is allowed
* Patients must have adequate organ function and performance status at the time of the CD8+ memory T-cell infusion, defined by the following:
* Total bilirubin =\< 4 mg/dL
* SGOT or SGPT =\< 4 x ULN
* Creatinine =\< 3 mg/dL or estimated creatinine clearance \>= 40ml/min
Exclusion Criteria:
* Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms
* Progressive hemato-lymphoid malignancy despite conventional therapy
* Acute leukemia not in remission
* Chronic myelogenous leukemia (CML)
* Active central nervous system (CNS) involvement of the underlying malignancy
* Human immunodeficiency virus (HIV) positive
* Pregnant or lactating
* Prior malignancy (EXCEPTION: diagnosed \> 5 years ago without evidence of disease, OR treated =\< 5 years ago but have a greater than 50% chance of life expectancy of \>= 5 years for that malignancy)
* Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant
* Ejection fraction \< 30%, or uncontrolled cardiac failure
* Diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted
* Total bilirubin \> 3 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) \> 4 x upper limit of normal (ULN)
* Creatinine \> 2 mg/dL and an estimated creatinine clearance =\< 40 mL/min
* Poorly controlled hypertension despite multiple antihypertensive medication OR
* Karnofsky performance status (KPS) \< 60%
* Note: Patients positive for hepatitis B and C will be evaluated on a case by case basis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02424968
Study Brief:
Protocol Section:
NCT02424968