- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02084563
Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms
Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms
The objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage.
Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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SP
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Sao Paulo, SP, Brasilien, 05651901
- Hospital Israelita Albert Einstein
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Acute Myeloid Leukemia-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Performance status (ECOG) between 0-2
- Adequate liver and kidney function
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- New York Heart Association class III and IV congestive heart failure
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Acute Myeloid Leukemia-Non-Intensive Chemotherapy
Inclusion Criteria:
- Diagnosis of AML according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
- No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts
- Adequate contraception for fertile men and women
- Non-eligible for intensive chemotherapy (as judged by the treating physician)
Exclusion Criteria:
- Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia)
- Pregnant women
- HIV-positivity
- Patient refuses to use adequate contraception
- History of hypersensibility to any of the used chemotherapy drugs
- Patient refuses to sign informed consent form
Chronic Myeloid Disorders:
Inclusion Criteria:
- Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria
- Age greater than 18 years
- Signed Informed Consent form
Exclusion Criteria:
- Patient refuses to sign informed consent form
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: AML-Intensive Chemotherapy
Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days. Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk:
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Induction chemotherapy for patients with AML eligible for intensive chemotherapy:
Andre navne:
Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors: -Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles
Andre navne:
Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
Andre navne:
Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML Conditioning regimen:
Andre navne:
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Andet: AML-Non-intensive chemotherapy
Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs. Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory. |
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
Andre navne:
Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
Andre navne:
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Ingen indgriben: Chronic Myeloid Disorders
Patients with Chronic Myeloid Disorders:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Prevalence of molecular and cytogenetic abnormalities
Tidsramme: 2 years
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As assessed by results of molecular and cytogenetic tests and frequency in the population studied
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival
Tidsramme: 5 years
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Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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Response rate
Tidsramme: 1 month
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Evaluate complete remission (CR) rate at 1 month for patients with Acute Myeloid Leukemia who received induction chemotherapy.
Complete remission was defined by the presence of < 5% blasts in the bone marrow (BM) with > 1 x 10^9/L neutrophils and >100x10^9/L platelets in the peripheral blood (PB)
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1 month
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Disease Free Survival
Tidsramme: 5 years
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Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy
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5 years
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Cumulative incidence of relapse and non-relapse mortality
Tidsramme: 5 years
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Evaluate 5-years cumulative incidence of relapse and non-relapse mortality in patients with Acute Myeloid Leukemia who achieve complete remission following induction chemotherapy
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5 years
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Number of participants with adverse events as a measure of safety and tolerability
Tidsramme: 1 year
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Evaluate hematological and non-hematological toxicity in patients with Acute Myeloid Leukemia treated according to the protocol.
Toxicity will be graded as per the National Cancer Institute Common Toxicity Criteria for Adverse Events v4.0.3
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1 year
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Cumulative Incidence of Transformation to Acute Myeloid Leukemia
Tidsramme: 5 years
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Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
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5 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Fabio P Santos, MD, Hospital Israelita Albert Einstein
- Studiestol: Nelson Hamerschlak, MD, PhD, Hospital Israelita Albert Einstein
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
- Patologiske processer
- Neoplasmer efter histologisk type
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Neoplasmer
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Leukæmi, myeloid
- Leukæmi, Myeloid, Akut
- Præleukæmi
- Myeloproliferative lidelser
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antibiotika, antineoplastisk
- Decitabin
- Cytarabin
- Daunorubicin
Andre undersøgelses-id-numre
- LMA Brasil
- 11/1714 (Anden identifikator: HIAE CEP)
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Kliniske forsøg med Induction Chemotherapy
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