a safety and tolerability study of cdx-301 with or without plerixafor for stem cell mobilization in matched related allogeneic donor/recipient sibling transplant pairs

Conditions: For Donors; Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling; For Recipients; Acute Myelogenous Leukemia (AML); Acute Lymphoblastic Leukemia (ALL); Myelodysplastic Syndrome (MDS); Chronic Myelogenous Leukemia (CML); Non-Hodgkins Lymphoma (NHL); Hodgkins Disease (HD); Chronic Lymphocytic Leukemia (CLL)

Summary: this is an open-label, multicenter, prospective pilot study of cdx-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). hla-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.


Eligibility criteria:
inclusion criteria: donors: * read, understood and provided written informed consent and willing to comply with all study requirements and procedures * 6 out of 6 hla-matched sibling * negative test for human immunodeficiency virus (hiv), hepatitis b, and hepatitis c * both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures * subjects should be in generally good health and without significant medical conditions, based upon pre-study medical history, physical examination, electrocardiogram (ecg), chest x- ray, and laboratory tests * meets all criteria to serve as a mobilized blood cell donor in accordance with all applicable individual transplant center criteria recipient: * read, understood and provided written informed consent and willing to comply with all study requirements and procedures * 6 out of 6 hla-matched sibling * both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures diagnosis of one of following: * acute myelogenous leukemia (aml) in 1st remission or beyond * acute lymphoblastic leukemia (all) in 1st remission or beyond * chronic myelogenous leukemia (cml) * chronic lymphoblastic leukemia (cll), relapsing after at least one prior regimen * myelodysplastic syndrome (mds), either intermediate 1,2, or high risk by ipi scoring system or transfusion dependent * non-hodgkins lymphoma (nhl) or hodgkins disease (hd) in 2nd or greater complete remission, partial remission, or in relapse * meets all criteria to serve as a transplant recipient in accordance with all applicable individual transplant center criteria exclusion criteria: donors: * unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing * prior treatment with any rhuflt3l product * any vaccination within 4 weeks prior to cdx-301 dosing * donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to cdx-301 dosing * any experimental treatment within 4 weeks prior to cdx-301 dosing * use of systemic immunosuppressive agents (excluding topical steroids) within 12 months prior to cdx-301 dosing. * history of first degree relatives with primary or secondary immunodeficiency to include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or psoriasis * history of tuberculosis infection * herpes zoster within 3 months prior to starting study drug * pregnant or nursing recipient: * unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing * prior allogeneic transplant * more than one prior autologous transplant * prior treatment with any rhuflt3l product * any vaccination within 4 weeks prior to transplant * uncontrolled infection at the time of the transplant conditioning regimen * pregnant or nursing * any condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the study outcome