- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01700673
Phase II Study of Azacitidine and Sargramostim as Maintenance Treatment for Poor-Risk AML or MDS
A Phase II Study of 5-Azacitidine (5AC) in Combination With Sargramostim (GM-CSF) as Maintenance Treatment, After Definitive Therapy With Either Stem Cell Transplant (SCT) or Cytarabine-based Chemotherapy, in Patients With Poor-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We propose a phase II study to determine the impact of maintenance therapy with 5-azacytidine and GM-CSF in patients with poor-risk AML or MDS, who are in remission after definitive treatment with either stem cell transplant or cytarabine-based consolidation chemotherapy.
In order to precede relapse and to avoid lead time bias, treatment would need to commence within 185 days of definitive therapy. Furthermore, approximately 50% of relapses occur within the first year and up to 80% within two years after SCT, therefore we would limit the duration of maintenance therapy to one year, followed by two years of follow-up.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age > 6 months
- Initial diagnosis of poor -risk AML or MDS (defined in section 3.2), treated with either stem cell transplant or cytarabine-based consolidation chemotherapy, within the past 60-185 days
- ECOG performance status 0-2
- No morphologic evidence of leukemia or active MDS as determined by JHH Hematopathologist independent review of a bone marrow aspirate and biopsy done following the completion of therapy and within 14 days prior to enrollment
- Peripheral blood count recovery: Neutrophil count ≥ 1000 /µL, platelet count ≥ 50x 109 /µL without platelet transfusions, and adequate hematocrit independent of red cell transfusions .
- No evidence of extramedullary leukemia, such as CNS or soft tissue involvement
- Adequate end organ function as measured by the following: AST and ALT < 4 x normal, total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert's syndrome, or ineffective erythropoiesis), creatinine < 2 x upper limit of normal
- Ability to give informed consent
- In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Exclusion Criteria:
- Patients with untreated or uncontrolled infections
- Patients with untreated or uncontrolled grade 3 or 4 GVHD
- Pregnancy and lactation
- Concurrent use of any other investigational agents.
- Known HIV-positive patients.
- Known hypersensitivity to 5AC or GM-CSF
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Myeloablative BMT
Azacitidine and sargramostim after myeloablative stem cell transplant
|
Azacitidine will be administered days 1-5 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
Sargramostim will be administered days 1-10 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
|
Eksperimentel: Non-myeloablative BMT
Azacitidine and sargramostim after non-myeloablative stem cell transplant
|
Azacitidine will be administered days 1-5 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
Sargramostim will be administered days 1-10 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
|
Eksperimentel: Standard consolidation
Azacitidine and sargramostim after standard consolidation
|
Azacitidine will be administered days 1-5 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
Sargramostim will be administered days 1-10 of a 28 day cycle.
Treatment is planned for a total of 12 cycles.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Two-year Relapse Free Survival of Patients
Tidsramme: 2 year
|
To evaluate the two-year relapse-free survival (RFS) of patients with poor-risk Acute Myeloid Leukemia (AML) or Myelodysplasia (MDS), who receive maintenance treatment with 5-Azacytidine (5AC) in combination with sargramostim (GM-CSF) during remission, following definitive therapy with either a stem cell transplant (SCT) or cytarabine-based consolidation chemotherapy.
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2 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hematologic Toxicity as Determined by Anemia
Tidsramme: 1 year
|
Percentage of patients with anemia, the most commonly reported hematologic toxicity, after receiving the combination of Azacitidine and sargramostim
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1 year
|
One-year RFS
Tidsramme: 1 year
|
We will report the number of participants with one year RFS
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1 year
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Overall Survival
Tidsramme: 2 years
|
Percentage of participants with overall survival at 2 years.
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2 years
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Margaret Showel, MD, JHU
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Myelodysplastiske syndromer
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Præleukæmi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Azacitidin
- Sargramostim
Andre undersøgelses-id-numre
- J1240
- P01CA015396 (U.S. NIH-bevilling/kontrakt)
- NA_00072223 (Anden identifikator: JHMIRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Azacitidine
-
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-
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Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCAfsluttet
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Henry Ford Health SystemRekrutteringMyeloid malignitetForenede Stater
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