- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01567059
Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
A Phase II Study of Tosedostat in Combination With Either Cytarabine or Decitabine in Newly Diagnosed AML or High-Risk MDS
Studieoversigt
Status
Betingelser
- Akut myeloid leukæmi hos voksne med 11q23 (MLL) abnormiteter
- Voksen akut myeloid leukæmi med Del(5q)
- Sekundær akut myeloid leukæmi
- Ubehandlet akut myeloid leukæmi hos voksne
- Tidligere behandlede myelodysplastiske syndromer
- Sekundære myelodysplastiske syndromer
- Voksen akut myeloid leukæmi med t(15;17)(q22;q12)
- de Novo Myelodysplastiske Syndromer
- Akut myeloid leukæmi med multilineage dysplasi
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine the 4 month survival and complete remission (CR) rates of tosedostat in combination with either cytarabine or decitabine in untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
SECONDARY OBJECTIVES:
I. To assess safety and tolerability of tosedostat in combination with either cytarabine or decitabine.
II. To determine the treatment related mortality defined as death within the first 30 days of beginning treatment.
III. To estimate rates of disease-free survival (DFS) and the 1 year overall survival (OS).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tosedostat orally (PO) once daily (QD) on days 1-35 and cytarabine intravenously (IV) on days 1-5.
ARM II: Patients receive tosedostat PO QD on days 1-35 and decitabine IV on days 1-5.
If the patient develops a significant increase in their circulating or bone marrow blast count, the subsequent cycle may be started as early as day 21 of the current cycle. In both arms, treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or partial CR (pCR) may receive 2 additional courses of treatment.
After completion of study treatment, patients are followed up every 3 months for 2 years and then annually for 3 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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Washington
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Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
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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:
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- All adults >= 60 years of age with untreated AML or high-risk MDS (10-19% marrow blasts) including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics; patients may be enrolled if they received prior treatment with hydroxyurea to control blood counts or demethylating agents specifically for the purpose of treating MDS
- Adults age 18 to 59 with untreated AML or high-risk MDS and a transplant-related mortality (TRM) score of >= 9.2; previous data suggests these people would have a 25% mortality with standard therapy, making this treatment a reasonable alternative
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2
- Serum creatinine =< 2.0 mg/dL; if serum creatinine > 2.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation
- Serum bilirubin =< 1.5 × upper limit of normal (ULN) (in the absence of Gilbert's syndrome)
- Aspartate transaminase (AST)/alanine transaminase (ALT) =< 3.0 × ULN
- Alkaline phosphatase =< 2.5 × ULN
- Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
- Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- Active uncontrolled infection
- Known infection with human immunodeficiency virus (HIV)
- Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study
- Uncontrolled angina or myocardial infarction within 6 months; patients with recent myocardial infarction apparently due to medical causes unrelated to underlying cardiac abnormalities must have a cardiac consult, and be cleared to participate in the research by the cardiologist prior to initiation of treatment and may be enrolled at the discretion of the primary investigator (PI) and treating physician
- Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)
- Diagnosed or treated for another malignancy within 1 year of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm I (tosedostat and cytarabine)
Patients receive tosedostat PO QD on days 1-35 and cytarabine IV on days 1-5.
|
Givet IV
Andre navne:
Given PO
Andre navne:
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Eksperimentel: Arm II (tosedostat and decitabine)
Patients receive tosedostat PO QD on days 1-35 and decitabine IV on days 1-5.
|
Givet IV
Andre navne:
Given PO
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients achieving CR
Tidsramme: 4 months after beginning treatment
|
Defined by Cheson et al.
|
4 months after beginning treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter histologisk type
- Neoplasmer
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Neoplastiske processer
- Forstadier til kræft
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Neoplasma Metastase
- Præleukæmi
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Glycinmidler
- Decitabin
- Azacitidin
- Cytarabin
- Glycin
- Tosedostat
Andre undersøgelses-id-numre
- 2566.00
- P30CA015704 (U.S. NIH-bevilling/kontrakt)
- NCI-2012-00274 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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Kliniske forsøg med Akut myeloid leukæmi hos voksne med 11q23 (MLL) abnormiteter
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National Cancer Institute (NCI)AfsluttetHIV-infektion | Klarcellet nyrecellekarcinom | Primær myelofibrose | Polycytæmi Vera | Essentiel trombocytæmi | Kronisk myelomonocytisk leukæmi | Tilbagevendende akut myeloid leukæmi hos voksne | Ekstranodal marginalzone B-celle lymfom i slimhinde-associeret lymfoidt væv | Nodal Marginal Zone B-celle lymfom og andre forholdForenede Stater
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Kliniske forsøg med cytarabin
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)RekrutteringRefraktær akut myeloid leukæmi | Sprænger mere end 5 procent af knoglemarvskerneholdige celler | Vedvarende sygdomForenede Stater
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Institute of Hematology & Blood Diseases Hospital...Rekruttering
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National Cancer Institute (NCI)RekrutteringAkut myeloid leukæmi | Kronisk myelomonocytisk leukæmi | Myelodysplastisk syndrom | Myeloproliferativ neoplasma | Akut myeloid leukæmi med multilineage dysplasi | Akut myeloid leukæmi efter cytotoksisk terapiForenede Stater
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