Preemptive Infusion of Donor Lymphocytes Depleted of TCR (Alpha-beta) + T Cells and CD19+ B Cells Following Allogeneic Stem Cell Transplantation DONOR LYMPHOCYTE INFUSION POST-TRANSPLANT

What's the purpose of this trial?

The purpose of this study is to reduce the risk of cancer relapse by giving a donor lymphocyte infusion (DLI) to boost the immune system early after a stem cell transplant so that leukemia cells that escaped chemotherapy can be detected and killed. This DLI will contain mostly lymphocytes that have graft versus tumor effect with low risk of graft versus host disease. Because the process of giving a DLI in the first four weeks after a transplant has not been approved by the Food and Drug Administration (FDA), this study in investigational (experimental).

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Subjects must have histologic or cytologic confirmation of ANY hematologic malignancy
* Allogeneic stem cell transplant is indicated as management of underlying hematologic malignancy.
* Participant has organ function (cardiac, lung and liver) considered adequate to undergo conditioning chemotherapy and allogeneic stem cell transplant in the assessment of the clinical program
* Participant has a 10/10 HLA-matched sibling donor OR has a HLA-haploidentical donor available (in the absence of a 10/10 HLA matched unrelated donor)
* The related transplant donor is willing, available and consents to undergo a second, non-mobilized leukapheresis for the procurement of donor lymphocytes
* The related transplant donor is 18 years of age or older
* Subjects must have the ability to understand and the willingness to sign a written informed consent document or provide assent.

Exclusion Criteria:

* Subject is unwilling to receive a prophylactic donor lymphocyte infusion per study protocol.
* The related donor is unwilling or unavailable to undergo a second, non- mobilized leukapheresis for the procurement of donor lymphocytes.
* Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry and for the duration of study participation. Women of child-bearing age must have documented negative pregnancy test prior to start of conditioning regimen for stem cell transplantation and a repeat negative pregnancy test prior to infusion of the lymphocyte product.
* Patients with any of the following organ function abnormalities: Left ventricular ejection fraction (LVEF) \< 45%; DLCO \<45% of expected value corrected for alveolar volume and hemoglobin; Serum Creatinine \>2 times the upper limit of normal.

Additional Trial Information

Phase 1

Enrollment: 10 patients (estimated)

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Trial Locations

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Ohio

Case Comprehensive Cancer Center Case Western Reserve University

Cleveland, OH

Not Yet Accepting
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