Phase
Condition
Hematologic Neoplasms
Treatment
Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with high-risk myeloid or lymphoid malignancies determined to be eligibleto undergo a related, allo-SCT using Disease Risk Index (DRI), including theconditions listed below. These criteria apply BEFORE cyto-reductive therapy givenwithin 28 days of planned conditioning:
Refractory acute myelogenous or lymphoid leukemia
Relapsed acute myelogenous or lymphoid leukemia
Myelodysplastic syndromes with 5 percent or more blasts
Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently,or second accelerated phase
Recurrent or refractory malignant lymphoma or Hodgkin's disease with less thana partial response at transplant
High risk chronic lymphocytic leukemia defined as no response or stable diseaseto the most recent treatment regimen
Other high risk hematologic malignancies for which allo-SCT is deemedclinically necessary per PI and based on institutional standards
The donor for the allo-SCT will have been identified prior to participantrecruitment and must be:
Related AND
Matched OR mismatched OR haploidentical at Human Leukocyte Antigen (HLA) HLA-A, -B, -C, and -DRB1 by molecular methods
Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
Ability to understand and willingness to sign written informed consent document
Willing to comply with all study procedures and be available for the duration of thestudy
Individuals in sexual relationships that could result in pregnancy or impregnationof their partner must use an acceptable method of contraception§ from enrollmentuntil 4 weeks after completing study treatment.
Exclusion
Exclusion Criteria:
Poor organ function as follows (According to the pre-transplant workups results):
Creatinine greater than or equal to 2.0 mg/dL
Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic PyruvicTransaminase (SGPT) greater than or equal to 5 x Upper Limit of Normal (ULN).Liver biopsy per clinician discretion.
Bilirubin greater than or equal to 3 x ULN (unless Gilbert's syndrome)
Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) less than 50 percentcorrected for hemoglobin
Left ventricular ejection fraction or shortening fraction less than 40 percent
NOTE: Exceptions to the above organ function exclusion criteria are allowable only with assent of the PI since the risks and benefits must be addressed for patients with potentially incurable hematologic malignancies. Such exceptions will be clearly documented in the subject's research record and will not be considered a deviation.
Patients with uncontrolled intercurrent illness
Patients with psychiatric illness/social situations that would limit compliance withstudy requirements
Study Design
Study Description
Connect with a study center
UW Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
UW Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available

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