- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00054340
Combination Chemotherapy and Antithymocyte Globulin in Reducing Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplantation For Myelodysplastic Syndrome or Myeloproliferative Disorder
Conditioning With Targeted Busulfan, Cyclophosphamide and Thymoglobulin for Allogeneic Marrow or Peripheral Blood Stem Cell (PBSC) Transplantation for Myelodysplasia and Myeloproliferative Disorders
RATIONALE: Combining antithymocyte globulin with combination chemotherapy before donor peripheral stem cell transplantation may reduce the chance of developing graft-versus-host disease following transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of combining antithymocyte globulin with busulfan and cyclophosphamide in reducing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for myelodysplastic syndrome or other myeloproliferative disorder.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Determine the incidence of acute graft-vs-host disease (GVHD) requiring therapy in patients with myelodysplastic syndromes or myeloproliferative disorders treated with busulfan, cyclophosphamide, and anti-thymocyte globulin prior to transplantation with filgrastim (G-CSF)-mobilized peripheral blood stem cells (or bone marrow) from related or unrelated donors.
- Determine the incidence of relapse and relapse-free survival in patients treated with this regimen.
- Determine the incidence of non-relapse mortality by day 100 and 1 year posttransplantation in patients treated with this regimen.
- Determine the incidence of Epstein-Barr virus reactivation, infections, and chronic GVHD in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of anti-thymocyte globulin.
- Conditioning and graft-vs-host disease (GVHD) prophylaxis: Patients receive oral busulfan every 6 hours on days -7 to -4 (16 doses), cyclophosphamide IV on days -3 and -2, and anti-thymocyte globulin IV over 3 hours on days -3, -2, and -1.
Cohorts of 15 patients receive adjusted doses of anti-thymocyte globulin to determine the optimal dose at which Epstein-Barr virus (EBV) activation and GVHD are reduced. The optimal dose is the dose at which 2 consecutive cohorts receive the same regimen.
- Stem cell transplantation: Patients undergo peripheral blood stem cell (PBSC) or bone marrow transplantation on day 0.
- Posttransplantation GVHD prophylaxis: Patients receive cyclosporine IV continuously on days -1 to 4 and then orally twice daily until day 180. Patients also receive methotrexate on days 1, 3, 6, and 11.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study within 2 years.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiesteder
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Myelodysplastic syndromes (including those that have evolved to acute myeloid leukemia)
Myeloproliferative disorders
- No chronic myelogenous leukemia
- Other diseases eligible for conditioning with targeted busulfan, cyclophosphamide, and anti-thymocyte globulin that are not candidates for other studies
Available related or unrelated donor compatible for HLA-A, -B, -C, DRB1, and DQB1
- A single allele mismatch at HLA-A, -B, -C, or DRB1 is allowed
PATIENT CHARACTERISTICS:
Age
- 65 and under
Performance status
- Not specified
Life expectancy
- No severe limitation due to other diseases
Hematopoietic
- Not specified
Hepatic
- AST no greater than 2 times normal
- No hepatic disease
Renal
- Creatinine no greater than 2 times upper limit of normal OR
- Creatinine clearance at least 50% for age, gender, and weight
Cardiovascular
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
Pulmonary
No severe or mild hypoxemia
- pO_2 at least 70 mm Hg and DLCO at least 70% of predicted OR
- pO_2 at least 80 mm Hg and DLCO at least 60% of predicted
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No growth factors given posttransplantation concurrently with methotrexate immunosuppression
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: H. Joachim Deeg, MD, Fred Hutchinson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- de novo myelodysplastiske syndromer
- tidligere behandlede myelodysplastiske syndromer
- sekundære myelodysplastiske syndromer
- akut myeloid leukæmi hos voksne med 11q23 (MLL) abnormiteter
- akut myeloid leukæmi hos voksne med inv(16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(15;17)(q22;q12)
- akut myeloid leukæmi hos voksne med t(16;16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(8;21)(q22;q22)
- barndoms myelodysplastiske syndromer
- tilbagevendende akut myeloid leukæmi hos voksne
- ubehandlet akut myeloid leukæmi hos voksne
- myelodysplastisk/myeloproliferativ sygdom, uklassificerbar
- polycytæmi vera
- essentiel trombocytæmi
- tilbagevendende akut myeloid leukæmi i barndommen
- kronisk eosinofil leukæmi
- kronisk neutrofil leukæmi
- kronisk idiopatisk myelofibrose
- ubehandlet akut myeloid leukæmi i barndommen og andre myeloide maligniteter
- graft versus host sygdom
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Præleukæmi
- Myeloproliferative lidelser
- Myelodysplastisk-myeloproliferative sygdomme
- Graft vs værtssygdom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Dermatologiske midler
- Antifungale midler
- Reproduktive kontrolmidler
- Abortfremkaldende midler, ikke-steroide
- Aborterende midler
- Folinsyreantagonister
- Calcineurin-hæmmere
- Cyclofosfamid
- Methotrexat
- Busulfan
- Antimfocyt serum
- Cyclosporin
- Cyclosporiner
Andre undersøgelses-id-numre
- 1723.00
- FHCRC-1723.00
- CDR0000270397 (Registry Identifier: PDQ)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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