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Clinical Trial
. 2008 Nov 15;112(10):4318-27.
doi: 10.1182/blood-2007-06-098020. Epub 2008 Aug 21.

Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies

Joanne Kurtzberg  1 , Vinod K Prasad, Shelly L Carter, John E Wagner, Lee Ann Baxter-Lowe, Donna Wall, Neena Kapoor, Eva C Guinan, Stephen A Feig, Elizabeth L Wagner, Nancy A Kernan; COBLT Steering Committee
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Clinical Trial

Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies

Joanne Kurtzberg et al. Blood. .

Abstract

Outcomes of unrelated donor cord blood transplantation in 191 hematologic malignancy children (median age, 7.7 years; median weight, 25.9 kg) enrolled between 1999 and 2003 were studied (median follow-up, 27.4 months) in a prospective phase 2 multicenter trial. Human leukocyte antigen (HLA) matching at enrollment was 6/6 (n = 17), 5/6 (n = 58), 4/6 (n = 111), or 3/6 (n = 5) by low-resolution HLA-A, -B, and high-resolution (HR) DRB1. Retrospectively, 179 pairs were HLA typed by HR. The median precryopreservation total nucleated cell (TNC) dose was 5.1 x 10(7) TNC/kg (range, 1.5-23.7) with 3.9 x 10(7) TNC/kg (range, 0.8-22.8) infused. The median time to engraftment (absolute neutrophil count > 500/mm(3) and platelets 50 000/muL) was 27 and 174 days. The cumulative incidence of neutrophil engraftment by day 42 was 79.9% (95% confidence interval [CI], 75.1%-85.2%); acute grades III/IV GVHD by day 100 was 19.5% (95% CI, 13.9%-25.5%); and chronic GVHD at 2 years was 20.8% (95% CI, 14.8%-27.7%). HR matching decreased the probability of severe acute GVHD. The cumulative incidence of relapse at 2 years was 19.9% (95% CI, 14.8%-25.7%). The probabilities of 6-month and 2-year survivals were 67.4% and 49.5%. Unrelated donor cord blood transplantation from partially HLA-mismatched units can cure many children with leukemias. The study was registered at www.clinicaltrials.gov as #NCT00000603.

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Figures

Figure 1
Figure 1
Cumulative incidence of engraftment and GVHD. (A) Cumulative incidences and 1-KM probability of neutrophil recovery. (B) Cumulative incidences and 1-KM probability of platelet engraftment of 50 000. (C) Cumulative incidences and 1-KM probability of acute GVHD grades III and IV. (D) Cumulative incidences and 1-KM probability of chronic GVHD.
Figure 2
Figure 2
Cumulative incidence of relapse. (A) Overall cumulative incidence and 1-M probability of relapse. (B) Cumulative incidence and 1-KM probability of relapse by stage of disease (first and second CR vs other).
Figure 3
Figure 3
Survival for patients with pediatric malignancies. (A) Overall survival. (B) Survival by recipient CMV pretransplantation serostatus. (C,D) Survival by disease status for patients with AML and ALL. (E,F) Survival by original and final HLA match.
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