- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00150878
Standard vs. Reduced-Intensity Conditioning in Patients With Acute Myeloid Leukemia in First Remission
Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Transplant-related deaths because of extramedullary toxicity and graft-versus host disease remain the major causes for treatment-failure in patients with AMl receiving allogeneic hematopoietic stem cell transplantation.
In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body- irradiation and fludarabine can be safely used in patients with AML at various disease stages. The best results could be achieved in patients who had been in complete remission by the time of inclusion.
Therefore this prospective trial was initiated to compare the new conditioning regimen with the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first remission.
After having achieved complete remission, and giving informed consent, patients are stratified according to marrow cytogenetics, age and type of induction therapy and subsequently randomized to receive on of the mentioned conditioning therapies.
The primary end-point will be non-relapse mortality. The hypothesis would be, that the one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of 5%, 252 patients will have to be randomized.
Secondary endpoints include:
3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4 extramedullary toxicity
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Dresden, Tyskland, 01307
- Medizinische Klinik und Poliklinik I
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of acute myeloid leukemia in first remission
- Standard-or high-risk marrow cytogenetics
- HLA-matched related or unrelated donor available (in case of high-risk disease)
- Age 18 to 60
- Informed consent
- Consent of donor to donate peripheral blood stem cells
- sufficient liver function (elevation of transferases < 2.5 x upper limit)
Exclusion Criteria:
- AML with t(5;17)
- AML with t((8;21)
- clinically relevant heart failure (NYHA II-IV)
- Renal failure (creatinine > 200 µg/ml)
- Liver function failure (bilirubin > 3 mg/dl)
- Concomitant Neurological or psychiatric disease
- Contraindications to receive prescribed study medication
- HIV infection
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 12 Gy/Cyclophosphamide
Standard intensity conditioning
|
Preparation before allogeneic transplantation
|
Eksperimentel: 8 Gy /Fludarabine
Reduced-intensity conditioning
|
Preparation before allogeneic transplantation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment-related mortality at 12 months after transplantation
Tidsramme: 12 months
|
Proportion of patients dying without prior relapse
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Disease-free and Overall survival
Tidsramme: 5 years
|
Proportion of patients alive without relapse
|
5 years
|
Grade 3-4 extramedullary toxicity
Tidsramme: 100 days
|
Percentage of patients with grade II-IV acute GvHD
|
100 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Gerhard Ehninger, MD, Director of Med. Klink und Poliklinik I, Technical University Dresden
Publikationer og nyttige links
Generelle publikationer
- Stelljes M, Bornhauser M, Kroger M, Beyer J, Sauerland MC, Heinecke A, Berning B, Scheffold C, Silling G, Buchner T, Neubauer A, Fauser AA, Ehninger G, Berdel WE, Kienast J; Cooperative German Transplant Study Group. Conditioning with 8-Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia. Blood. 2005 Nov 1;106(9):3314-21. doi: 10.1182/blood-2005-04-1377. Epub 2005 Jul 14.
- Fasslrinner F, Schetelig J, Burchert A, Kramer M, Trenschel R, Hegenbart U, Stadler M, Schafer-Eckart K, Batzel M, Eich H, Stuschke M, Engenhart-Cabillic R, Krause M, Dreger P, Neubauer A, Ehninger G, Beelen D, Berdel WE, Siepmann T, Stelljes M, Bornhauser M. Long-term efficacy of reduced-intensity versus myeloablative conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: retrospective follow-up of an open-label, randomised phase 3 trial. Lancet Haematol. 2018 Apr;5(4):e161-e169. doi: 10.1016/S2352-3026(18)30022-X. Epub 2018 Mar 14.
- Bornhauser M, Kienast J, Trenschel R, Burchert A, Hegenbart U, Stadler M, Baurmann H, Schafer-Eckart K, Holler E, Kroger N, Schmid C, Einsele H, Kiehl MG, Hiddemann W, Schwerdtfeger R, Buchholz S, Dreger P, Neubauer A, Berdel WE, Ehninger G, Beelen DW, Schetelig J, Stelljes M. Reduced-intensity conditioning versus standard conditioning before allogeneic haemopoietic cell transplantation in patients with acute myeloid leukaemia in first complete remission: a prospective, open-label randomised phase 3 trial. Lancet Oncol. 2012 Oct;13(10):1035-44. doi: 10.1016/S1470-2045(12)70349-2. Epub 2012 Sep 7.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9005-2003
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