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Completed

NCT Number: NCT02084563

Study of Molecular and Genetic Abnormalities in Patients With Myeloid 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.

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Key information

Conditions

Acute Myeloid Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Bone Marrow Neoplasms Chronic Disease Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Myeloproliferative Neoplasms Myeloproliferative/Myelodysplastic Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Polycythemia Vera Primary Myelofibrosis Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05651901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction chemotherapy

Drug

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

Other names: 7+3, Ara-C, Daunorubicin, Anthracycline, 3+7

Consolidation Chemotherapy

Drug

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

Other names: Ara-C, Cytarabine

Autologous Stem Cell Transplantation

Drug

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

Other names: ASCT, Autologous Bone Marrow Transplantation, ABMT

Allogeneic Stem Cell Transplantation

Drug

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

Other names: AlloSCT, Allogeneic Bone Marrow Transplantation

Low dose cytarabine

Drug

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)

Other names: Low dose ara-C, LDAC

decitabine

Drug

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)

Other names: 2-aza-5´-deoxycytidine, Dacogen, DAC

Primary outcomes

  1. Prevalence of molecular and cytogenetic abnormalities

    Time frame: 2 years

    As assessed by results of molecular and cytogenetic tests and frequency in the population studied

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    Evaluation of 5-years overall survival in patients with Acute Myeloid Leukemia, Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms

  2. Response rate

    Time frame: 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)

  3. Disease Free Survival

    Time frame: 5 years

    Evaluate rate of 5-years disease-free survival in patients with Acute Myeloid Leukemia who enter complete remission after induction chemotherapy

  4. Cumulative incidence of relapse and non-relapse mortality

    Time frame: 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. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 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

  6. Cumulative Incidence of Transformation to Acute Myeloid Leukemia

    Time frame: 5 years

    Evaluate 5-years incidence of transformation to Acute Myeloid Leukemia in patients with Myeloproliferative Neoplasms, Myelodysplastic Syndromes and Myeloproliferative/Myelodysplastic Neoplasms

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 12, 2014
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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