This pilot phase I trial studies chemotherapy and recombinant interferon alfa-2B followed by donor lymphocyte (white blood cell) infusion in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has returned (relapsed) after donor stem cell transplant. Chemotherapy works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Recombinant interferon alfa-2B is a substance that can improve the body’s natural response and may interfere with the growth of cancer cells. Donor lymphocyte infusion is a type of therapy in which lymphocytes from the blood of a donor are given to a patient and they may be able to stimulate the patient's immune system to kill cancer cells. Giving conventional chemotherapy, recombinant interferon alfa-2B followed by donor lymphocyte infusion may kill more cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02331706.
PRIMARY OBJECTIVES:
I. Proportion of subjects who start chemotherapy and are able to complete prescribed course of therapy (chemotherapy, recombinant interferon alfa-2B [IFN-alfa], and donor lymphocyte infusion [DLI]).
SECONDARY OBJECTIVES:
I. To assess the rate of complete remission (CR) by day 100 after DLI.
II. To estimate 1-year overall survival (OS).
III. To estimate 1-year disease-free survival (DFS) in subjects who achieve remission.
IV. To estimate incidence of grade II and III-IV acute graft-versus-host disease (GVHD).
V. To estimate incidence of chronic GVHD.
VI. To describe treatment-related mortality (TRM).
VII. Laboratory based immune studies using several different assays will be done on bone marrow biopsy aspirates, peripheral blood, and plasma to identify important immune components that may identify responders versus (vs) non-responders.
VIII. Descriptive statistical analysis will be performed with data to be presented on individuals and in aggregate.
OUTLINE:
Patients receive induction chemotherapy according to their treating physician's choice for 10-14 days. Beginning 14-35 days after start of chemotherapy, patients receive DLI. Patients also receive recombinant interferon alfa-2B subcutaneously (SC) for 34 days beginning 5 days before DLI.
After completion of study treatment, patients are followed up weekly for 1 month, monthly for 3 months, and then every 3 months for 2 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorDavid L. Porter