Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms

7 november 2016 uppdaterad av: Fabio Pires de Souza Santos, Hospital Israelita Albert Einstein

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

455

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Brasilien
    • SP
      • Sao Paulo, SP, Brasilien, 05651901
        • Hospital israelita Albert Einstein

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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:

  • Low risk patients: Consolidation chemotherapy or Autologous stem cell transplantation
  • Intermediate and high-risk patients: Allogeneic stem cell transplantation Patients who do not achieve CR may receive one second induction cycle, and if CR is achieved may proceed to post-remission therapy as per above. Patients who do not achieve CR after two cycles of induction will be deemed refractory and removed from the study.
Läkemedel: Induction Chemotherapy

Induction chemotherapy for patients with AML eligible for intensive chemotherapy:

  • Cytarabine 200 mg/m2 IV continuous infusion days 1-7
  • Daunorubicin 90 mg/m2 intravenous piggyback days 1-3
Andra namn:
  • Ara-C
  • Antracyklin
  • 7+3
  • Daunorubicin
  • 3+7
Läkemedel: Consolidation Chemotherapy

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

Andra namn:
  • Ara-C
  • Cytarabin
Läkemedel: Autologous Stem Cell Transplantation

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:

  • Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4
  • Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2
Andra namn:
  • ASCT
  • ABMT
  • Autologous Bone Marrow Transplantation
Läkemedel: Allogeneic Stem Cell Transplantation

Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML

Conditioning regimen:

  • Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4
  • Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2 or Fludarabine 40 mg/m2 IV once daily days -7 to -4
Andra namn:
  • AlloSCT
  • Allogen benmärgstransplantation
Övrig: 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.
Läkemedel: Low Dose Cytarabine

Chemotherapy for patients with AML who are not fit for intensive chemotherapy:

  • Cytarabine 60 mg/m2 subcutaneous (SQ) bid days 1-5 (until CR or maximum 4 cycles)
  • Cytarabine 40 mg/m2 SQ bid days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)
Andra namn:
  • Low dose ara-C
  • LDAC
Läkemedel: Decitabine

Chemotherapy for patients with AML who are not fit for intensive chemotherapy:

  • Decitabine 20 mg/m2 IV once daily days 1-10 (until CR or maximum 4 cycles)
  • Decitabine 20 mg/m2 IV once daily days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)
Andra namn:
  • Dacogen
  • DAC
  • 2-aza-5´-deoxycytidine
Inget ingripande: Chronic Myeloid Disorders

Patients with Chronic Myeloid Disorders:

  • Myeloproliferative Neoplasms
  • Myelodysplastic Syndromes
  • Myeloproliferative/Myelodysplastic Neoplasms

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prevalence of molecular and cytogenetic abnormalities
Tidsram: 2 years
As assessed by results of molecular and cytogenetic tests and frequency in the population studied
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival
Tidsram: 5 years
Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
5 years
Response rate
Tidsram: 1 month
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)
1 month
Disease Free Survival
Tidsram: 5 years
Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy
5 years
Cumulative incidence of relapse and non-relapse mortality
Tidsram: 5 years
Evaluate 5-years cumulative incidence of relapse and non-relapse mortality in patients with Acute Myeloid Leukemia who achieve complete remission following induction chemotherapy
5 years
Number of participants with adverse events as a measure of safety and tolerability
Tidsram: 1 year
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
1 year
Cumulative Incidence of Transformation to Acute Myeloid Leukemia
Tidsram: 5 years
Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms
5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospital Israelita Albert Einstein

Utredare

  • Studierektor: Fabio P Santos, MD, Hospital israelita Albert Einstein
  • Studiestol: Nelson Hamerschlak, MD, PhD, Hospital israelita Albert Einstein

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 november 2016

Studieregistreringsdatum

Först inskickad

2 januari 2013

Först inskickad som uppfyllde QC-kriterierna

10 mars 2014

Första postat (Uppskatta)

12 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

8 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LMA Brasil
  • 11/1714 (Annan identifierare: HIAE CEP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera