Session: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II
Hematology Disease Topics & Pathways:
Adult, Biological, Therapies, Study Population, Clinically relevant, transplantation
Methods: Patients with hematological malignancies and adequate organ function were eligible for this study if they had 8/8 matched related or matched unrelated or a haploidentical related donor. They received a fixed dose of busulfan 80mg/m2 on day -13 and -12. Fludarabine 40mg/m2 was given on day -6 to -2 followed by busulfan dosed to achieve target area under the curve (AUC) of 20,000 μmol-min for the whole course based on pharmacokinetic studies done on day -13 and -6. Thiotepa 5mg/kg was given on day -7 to recipients of haploidentical donor. Graft-versus-host disease (GVHD) prophylaxis included cyclophosphamide 50mg/kg given on day 3 and 4 and tacrolimus. Haploidentical donor recipients and later MUD recipients received mycophenolate mofetil, in addition.
Results: Forty five patients with a median age of 48 (15-65) years were enrolled. Twenty four patients had AML or MDS, 9 CML or MPD, 5 Lymphoma, 4 Myeloma and 3 ALL. Donors were matched sibling 11, matched unrelated 18, and haploidentical 16. Disease risk index was high in 13, intermediate in 27, and low in 5 patients. Sixteen patients had comorbidity score of 3 or higher.
With a median follow up of 12 months (1-22), 1 year OS, PFS, NRM and relapse rates were 73% (60-88%), 68% (54-84%), 17% (5-29%), and 17% (5-29%) (Table), respectively. There were no graft failures. The median time to neutrophil engraftment was 16 days (13-39), and that of platelets (≥ 20K/µL) was 26 days (11-167). Day 100 grade II-IV and III-IV acute GVHD rates were 42% (27-57%) and 7% (95% CI 0-15%), respectively; 1-year chronic GVHD and extensive chronic GVHD rates were 11% (1-21%) and 8% (0-17%), respectively. One year OS in recipients of matched sib, matched unrelated and haploidentical donor were 89% (71-100%), 66% (45-95%), and 69% (49-96%) respectively and were not significantly different (P=0.31).
Disclosures: Bashir: Amgen: Other: Advisory board; Celgene: Research Funding; Spectrum: Other: Advisory board; Takeda: Other: Advisory board, Research Funding; KITE: Other: Advisory board. Oran: Celgene: Consultancy, Research Funding; ASTEX: Research Funding; AROG pharmaceuticals: Research Funding. Rezvani: Affirmed GmbH: Research Funding. Shpall: Affirmed GmbH: Research Funding. Champlin: Sanofi: Research Funding; Otsuka: Research Funding.
See more of: Oral and Poster Abstracts