This document addresses the use of donor lymphocyte infusions after an allogeneic hematopoietic progenitor cell transplant to treat a hematologic malignancy (e.g., cancer of the blood or bone marrow, such as leukemia or lymphoma). Donor lymphocyte infusion (DLI) is a form of adoptive immunotherapy in which a transplant recipient is infused with lymphocytes obtained in a leukapheresis procedure from the original allogeneic hematopoietic progenitor cell donor. This procedure attempts to induce a beneficial graft-versus-leukemia (GVL) response without the need for additional bone marrow harvest from the donor or further high-dose chemotherapy for the recipient.

Note: For use of donor lymphocyte infusion as adoptive immunotherapy, please see:

• MED.00024 Adoptive Immunotherapy and Cellular Therapy

Clinical Indications

Medically Necessary:

Donor* lymphocyte infusion is considered medically necessary for individuals following a medically necessary allogeneic (myeloablative or non-myeloablative) hematopoietic progenitor cell transplant used to treat a hematologic malignancy.

*Note: The donor for the lymphocytes is the same individual whose hematopoietic progenitor cells were used for the transplant procedure.

Collection and cryopreservation of donor lymphocytes is considered medically necessary prior to, at the time of, or after a medically necessary allogeneic or non-myeloablative allogeneic hematopoietic progenitor cell transplant.

Not Medically Necessary:

Donor lymphocyte infusion is considered not medically necessary in all other cases.

Genetic modification of donor lymphocytes as an adjunct to donor lymphocyte infusion is considered not medically necessary.