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To browse Academia. Skip to main content. By using our site, you agree to our collection of information through the use of cookies. To learn more, view our Privacy Policy. Log In Sign Up. Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors Blood. Nicole Onetto. Phase II trial of recombinant human granulocyte-macrophage colony-stimulating factor in patients undergoing allogeneic bone marrow transplantation from unrelated donors.

From bloodjournal. For personal use only. Copyright by The American Society of Hematology; all rights reserved. Bianco, C. Appelbaum, John Hansen, and Jack W. Singer The safety and possible efficacy of recombinant human versely increase the incidence of graft rejection or increase granulocyte-macrophage colony-stimulating factor rhGM- the incidence and severity of acute graft-versus-host disease.

CSF were evaluated in 40 consecutive patients who received The median day the absolute neutrophil count reached zyxwvuts transplants from unrelated donors. These patients were Nevertheless, the numbers of febrile days and septicemic compared with 78 historical patients who received trans- episodes within the first 28 days in patients who received plants from unrelated donors who did not receive rhGM-CSF.

The probability of relapse in patients with myeloid from BMT? Patients with hematologic neoplasia or severe human granulocyte-macrophage colony-stimulating factor aplastic anemia who were undergoing allogeneic BMT from rhGM-CSF. Address reprints requests to John Nemunaitis, MD, I1I Oncology, the results were compared with those in 78 consecutive historical patients who received transplants from unrelated donors from May 1, to Februaly 24, Seattle, WA Donor selection of historical and studypatients.

Histocompatibil- The publication costs of this article were defrayed in part by page ity testing for all patients and donors was performed in the FHCRC charge payment. This article must therefore be hereby marked laboratory. To prevent acquisition of primary cytomegalovirus infection, all seronegative patients who had seronegative marrow donors received red cell and platelet transfusions exclusively from seronegative blood donors.

Seroposi- tive patients did not receive screened blood. Vital signs were monitored every 4 hours. MDS Definition of infection. Patients were considered to be bactere- Donorlrecipient histocompatibility mic if at least one positive blood culture for bacteria other than HLA matched coagulase-negative staphylococcus was obtained in a febrile pa- HLA mismatched tient.

Fungemia was defined as at least one Cyclosporinelprednisone positive blood culture in a febrile patient. Patients who developed Cyclosporinelmethotrexate bacteremia, candidemia, or who had biopsy-confirmed histologic or Laminar air flow room culture evidence of bacterial or fungal organisms from closed body Intravenous gamma globulin organs were considered to be infected. Transplant procedure.

GVHD prophylaxis consistent of methotrexate was parentheses. Patients who did not receive methotrexate received cyclo- sporine at a similar dose and schedule as described above.

They also cells in a modified microcytotoxicity assay. The mixed lymphocyte reaction Smdy design. All patients received rhGM-CSF specific activ- was performed according to standard methods with reactivity ity, 5 x lo7 colony-forming unitslmg; yeast-derived product, sup- expressed as a relative response. DNA restriction fragment length polymorphism detected with Stathticul unulysis.

Donor compatibility with a recipi- were compared between the study patients and historical controls ent was based on matching for the HLA-A, B, and D loci. For using the two-tailed Fisher's exact test for categorical variables eg, patients under 35 years of age, donors incompatible for a single sex and disease stage and the Wilcoxon rank-sum test" for HLA locus were allowed if there was class I disparity within a continuous variables eg, age and marrow cell dose. Supportive cure.

Twelve of the historical bilirubin and creatinine between 0 and 28 days were compared using the Wilcoxon rank-sum test. Three died before day 25, one after discontinuation of the drug. Three patients did not relapsed on day 43, and three require platelet transfusions survive to complete their courses and one patient devel- more than days after BMT. Forty-one percent of oped recurrent disease.

No patients within the first 28 days. CSF patients was 1. Parameters of hematologic recov- tients received all four projected doses of methotrexate. The median historical patients. Because the ANC had not patients was 3. Two patients transplanted for acute lympho- zyxwvut received 21 doses of rhGM-CSF and those who received 28 zyxwvut doses.

Hematologic Recovery medianvalues No. Ol Grade Grade 2 Grade 3 Grade 4 zyxwvutsrqponm o. Two patients died of venoocclusive disease of the liver and one each died of relapse, infection, and multiorgan failure.

The probability of nonrelapse 0. A Kaplan-Meyer estimate of nonrelapse mortality of 40 treated patients. In a historical series of 17 patients transplanted with CML-CP from unrelated donors, four died before day historical patients. The purpose of this study was to test the safety and A hypothesis that may explain these observations is that possible efficacy of rhGM-CSF when administered to pa- suppression of endotoxemia may suppress GVHD.

Patients tients after BMT from unrelated donors. One concern with undergoing BMT in protected environments with gut decon- the use of rhGM-CSF in unrelated donor grafts was that it tamination have a lower incidence of infection, and reduced might increase the risk of marrow graft rejection.

Although severity and delayed onset of acute GVHD. The decrease in the had an increase in the frequency of autologous recovery, number of 'febrile days provides suggestive evidence for suggesting that GM-CSF might increase immunologic graft this. However, because comparison of patients who received the severity of acute GVHD.

Randomized, prospec- also downregulates IL-2 receptor expression on mono- tive studies are required. In the present study, the reduction in infection could not be attributed to earlier overall incidence of acute GVHD was similar to that of neutrophil recovery, because in this trial, most infections W 0 z W n zyxwvutsr "Ol 0. Because these con- clusions may be erroneous because historical patients were used for comparison, these data will require a randomized, tered to neutropenic mice before induction of bacterial or placebo-controlled trial for confirmation.

N Engl J Med , 2. Transplantation , 3. Behring Inst Mitt , N Engl J Med , tation of marrow from an unrelated donor. N Engl J Med , McGlave PB, Beatty P, Ash R, Hows JM: Therapy for chronic human granulocyte-macrophage colony-stimulating factor in graft myelogenous leukemia with unrelated donor bone marrow trans- failure following bone marrow transplantation.

Blood , plantation: Results in cases. Blood , 5. Bone Marrow Transpl, macrophage colony-stimulating factor following allogeneic bone 6. Blood , Manual of Tissue Typing Techniques. Transplantation cal bone marrow transplantation: Donor selection and recipient , monitoring, in Rose N, Friedman H, Fahey J eds : Manual of 8. N Engl J Med Blood , marrow grafts from HLA-identical siblings.

J Exp Med , leukemia. Oakland, CA, Holden-Day, ,p 5 responses. J Immunol, zyxwvutsr J Am Stat Assoc , Pet0 R, Pet0 J: Asymptotically efficient rank invariant test zyxwvutsr procedures with discussion.

Pepe MS: Inference for events with dependent risks in multiple endpoint studies. J Am Stat Assoc in press Enhanced survival but reduced engraftment in murine recipients of cyte-macrophagecolony-stimulatingfactor down-regulates expres- sion of IL-2 receptor on human mononuclear phagocytes by induction of prostaglandine. J Immunol, Blood , J Natl Cancer Inst , following transplantation of T-cell depleted histoincompatible Blood , marrow transplanted mice to bacterial infection induced by recom- Blood , ability of recombinant murine granulocyte-macrophage colony- J Infect Dis , factor interleukin 1 by macrophages activated with colony- J Immunol, nant murine granulocyte-macrophage colony-stimulating factor J Infect Dis , lating factor enhances monocyte cytotoxicity and secretion of Blood , Related Papers.

Use of recombinant human granulocytemacrophage colony-stimulating factor rhGM-CSF in autologous marrow transplantation for lymphoid malignancies.

By Jack Singer. Recombinant human granulocyte-macrophage colony-stimulating factor accelerates engraftment kinetics after allogeneic bone marrow transplantation for childhood acute lymphoblastic leukemia.


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