title: Feasibility of low-dose interleukin-2 therapy following T-cell-depleted nonmyeloablative allogeneic hematopoietic stem cell transplantation from HLA-matched or -mismatched family member donors.
abstract: BACKGROUND
  High relapse rates and infections remain primary causes of failure in nonmyeloablative transplantation. Interleukin-2 (IL-2) may stimulate the immune system and improve outcomes. The primary objective of this pilot study was to evaluate the feasibility of administering IL-2 following a T-cell-depleted nonmyeloablative hematopoietic stem cell transplant.
  
  
  METHODS
  Patients received T-cell-depleted nonmyeloablative transplant from a matched or mismatched related donor. Those with allogeneic engraftment, <grade 2 acute GVHD at time of study entry, and no severe end organ damage were eligible and received IL-2 starting 6 weeks after the first day of stem cell infusion. Patients received 1 mu/m2 daily for 5 days each week for 4 weeks followed by a 2-week rest period for a 6-week cycle to continue for up to 1 year.
  
  
  RESULTS
  Eight patients aged 28-69 years were treated. Significant toxicities were limited to GVHD of the skin ≤grade 2 in 3 patients and severe fatigue in 4 patients, limiting the duration of therapy. Two of the 8 patients died of relapsed disease and 1 from CMV. With a median overall duration of follow-up of survivors of 48 months, 5 patients (63%) remain alive and in continuous complete remission.
authors.affiliation: Department of Medicine, Division of Cellular Therapy, Duke University Medical Center, Durham, North Carolina 27710, USA. rizzi003@mc.duke.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Rizzieri
authors.forename: Christopher
authors.initials: C
authors.lastname: Crout
authors.forename: Robert
authors.initials: R
authors.lastname: Storms
authors.forename: Jared
authors.initials: J
authors.lastname: Golob
authors.forename: Gwynn D
authors.initials: GD
authors.lastname: Long
authors.forename: Cristina
authors.initials: C
authors.lastname: Gasparetto
authors.forename: Keith M
authors.initials: KM
authors.lastname: Sullivan
authors.forename: Mitchell
authors.initials: M
authors.lastname: Horwitz
authors.forename: John
authors.initials: J
authors.lastname: Chute
authors.forename: Anand S
authors.initials: AS
authors.lastname: Lagoo
authors.forename: Ashley
authors.initials: A
authors.lastname: Morris
authors.forename: Anne
authors.initials: A
authors.lastname: Beaven
authors.forename: Yiping
authors.initials: Y
authors.lastname: Yang
authors.forename: Bercedis
authors.initials: B
authors.lastname: Peterson
authors.forename: Zhiguo
authors.initials: Z
authors.lastname: Li
authors.forename: Nelson J
authors.initials: NJ
authors.lastname: Chao
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D005190:Family; D005221:Fatigue / Q000209:etiology; D005240:Feasibility Studies; D006086:Graft vs Host Disease / Q000276:immunology; D006680:HLA Antigens / Q000276:immunology*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006648:Histocompatibility; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000276:immunology / Q000628:therapy*; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D009657:North Carolina; D010865:Pilot Projects; D013997:Time Factors; D014019:Tissue Donors; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D006680:HLA Antigens; D007166:Immunosuppressive Agents; D007376:Interleukin-2