Clinical Trials /

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT03164057

Description:

The overall aim of this study is to determine if epigenetic priming with a DNA methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries evidence of a clinical efficacy signal as determined by minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as well as total reduction in DNA methylation and outcome assessments will be done to simultaneously obtain preliminary biological and clinical data for each DMTi in parallel. PRIMARY OBJECTIVES: - Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks. - Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients. SECONDARY OBJECTIVES - Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi. - Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Myeloid Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
  • Official Title: A Phase II Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: AML16
  • SECONDARY ID: NCI-2017-00928
  • NCT ID: NCT03164057

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
AzacitidineVidaza®AZA+ADE | AZA+FLAG+Ida | AE | MA
DecitabineDacogen®DAC+ADE | DAC+FLAG+Ida | AE | MA
CytarabineAra-C, Cytosar®AZA+ADE | AZA+FLAG+Ida | AE | MA
DaunorubicinDaunomycin, Cerubidine®AZA+ADE | AZA+FLAG+Ida | AE | MA
EtoposideVepesid®, VP-16, Etoposide Phosphate, Etopophos®AZA+ADE | AZA+FLAG+Ida | AE | MA
IdarubicinIdamycin PFS®AZA+ADE | AZA+FLAG+Ida | AE | MA
FludarabineFludara®AZA+ADE | AZA+FLAG+Ida | AE | MA
MitoxantroneNovantrone®AZA+ADE | AZA+FLAG+Ida | AE | MA
Erwinia asparaginaseAsparaginase Erwinia chrysanthemi, Erwinaze®, Crisantaspase®AZA+ADE | AZA+FLAG+Ida | AE | MA | Asp+AraC
SorafenibNexavar®AZA+ADE | AZA+FLAG-Ida+Sor | AE | MA+Sor | Asp+AraC+Sor
G-CSFNeupogen, FilgrastimAZA+ADE | AZA+FLAG+Ida | AE | MA
DexrazoxaneZinecard®AZA+ADE | AZA+FLAG+Ida | AE | MA
Stem Cell TransplantSCTAZA+ADE | AZA+FLAG+Ida+Sor | MA+Sor | Asp+AraC+Sor

Purpose

The overall aim of this study is to determine if epigenetic priming with a DNA methyltransferase inhibitor (DMTi) prior to chemotherapy blocks is tolerable and carries evidence of a clinical efficacy signal as determined by minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS). Tolerability for each of the agents, as well as total reduction in DNA methylation and outcome assessments will be done to simultaneously obtain preliminary biological and clinical data for each DMTi in parallel. PRIMARY OBJECTIVES: - Evaluate the tolerability of five days of epigenetic priming with azacitidine and decitabine as a single agent DMTi prior to standard AML chemotherapy blocks. - Evaluate the change in genome-wide methylation burden induced by five days of epigenetic priming and the association of post-priming genome-wide methylation burden with event-free survival among pediatric AML patients. SECONDARY OBJECTIVES - Describe minimal residual disease levels following Induction I chemotherapy in patients that receive DMTi. - Estimate the event-free survival and overall survival of patients receiving a DMTi prior to chemotherapy courses.

Detailed Description

      To determine tolerability, priming with DMTi (azacitidine or decitabine) will be limited to
      Induction I and II during Part 1 of the study. If DMTi treatment is tolerated during Part 1,
      the investigators will go on to an Expansion Phase (Part 2) that includes DMTi priming prior
      to all chemotherapy blocks.

      Treatment will consist of 5 blocks of conventional chemotherapy: Induction I, Induction II,
      Intensification I, Intensification II, and Intensification III over approximately 5 months.

      RANDOMIZATION: Patients will be randomized to receive one of two DMTi (azacitidine or
      decitabine) for 5 days prior to Induction I. Intrathecal (ITHMA) treatments will be given
      right before treatment on this study or on Day 1 of Induction I treatment. Leucovorin will be
      given 24-30 hours following ITHMA.

      INDUCTION I CHEMOTHERAPY: Patients receive cytarabine, daunorubicin, and etoposide.

      INDUCTION II CHEMOTHERAPY; Patients receive their assigned DMTi for 5 days followed by
      fludarabine, cytarabine, G-CSF, and idarubicin.

      Patients are then evaluated and assigned to either the low-risk arm, intermediate-risk arm,
      or the high-risk arm for Intensification therapy.

      Patients with ≥ 5% blasts following Induction II will be considered refractory and will go
      off therapy. The rare high risk patient with an MRD < 0.1% following Induction I may proceed
      directly to stem cell transplant (SCT) after Induction II - if a suitable donor is available
      and the transplant can be performed without delay.

      INTENSIFICATION I CHEMOTHERAPY - LOW-RISK AML, INTERMEDIATE-RISK AML, and HIGH-RISK AML with
      no donor: Patients receive cytarabine and etoposide. After administration of 5 days of a DMTi
      prior to Inductions I and II satisfies a tolerability determination criterion, patients will
      also receive their randomly assigned DMTi for five days prior to cytarabine and etoposide.

      INTENSIFICATION II CHEMOTHERAPY - LOW RISK AML, INTERMEDIATE-RISK AML, and HIGH-RISK AML with
      no donor: Patients receive mitoxantrone and cytarabine. After administration of 5 days of a
      DMTi prior to Inductions I and II satisfies a tolerability determination criterion, patients
      will also receive their randomly assigned DMTi for five days prior to mitoxantrone and
      cytarabine.

      INTENSIFICATION I CHEMOTHERAPY - HIGH-RISK AML with a donor: Patients receive mitoxantrone
      and cytarabine followed by stem cell transplant (SCT). Treatment related AML patients who
      have a donor but are not able to receive a SCT without delay will proceed to HR
      Intensification III and receive erwinia asparaginase and cytarabine. After administration of
      5 days of a DMTi prior to earlier courses satisfies a tolerability criterion, patients will
      also receive their randomly assigned DMTi for five days prior to mitoxantrone and cytarabine
      or erwinia asparaginase and cytarabine.

      Treatment related AML patients that are not able to receive a SCT should go off treatment
      following Intensification II.

      INTENSIFICATION III CHEMOTHERAPY - INTERMEDIATE-RISK AML and HIGH-RISK AML with no donor:
      Patients receive erwinia asparaginase and cytarabine. After administration of 5 days of a
      DMTi prior to earlier courses satisfies a tolerability criterion, patients will also receive
      their randomly assigned DMTi for five days prior to erwinia asparaginase and cytarabine.
    

Trial Arms

NameTypeDescriptionInterventions
AZA+ADE | AZA+FLAG+Ida | AE | MAExperimentalPart 1 Tolerability with AZA - Low Risk Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and then receive low-risk intensifications I & II without azacitidine. Interventions: azacitidine, cytarabine, daunorubicin, etoposide,dexrazoxane, fludarabine, idarubicin, G-CSF, mitoxantrone., ITMHA.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida | AE | MAExperimentalPart 1 Tolerability with DAC - Low Risk Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and then receive low-risk Intensifications I & II without decitabine. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • G-CSF
  • Dexrazoxane
AZA+ADE | AZA+FLAG+Ida | AZA+AE | AZA+MAExperimentalPart 2 Dose Expansion with AZA - Low Risk Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and low- risk Intensifications I & II. Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, ITMHA.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida | DAC+AE| DAC+MAExperimentalPart 2 Dose Expansion with DAC - Low Risk Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and low-risk Intensifications I & II. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • G-CSF
  • Dexrazoxane
AZA+ADE | AZA+FLAG+Ida | AE | MA | Asp+AraCExperimentalPart 1 Tolerability with AZA - Intermediate Risk Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and then receive intermediate risk Intensifications I, II & III without azacitidine. Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA,
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida | AE | MA | Asp+AraCExperimentalPart 1 Tolerability with DAC - Intermediate Risk Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and then receive intermediate-risk Intensifications I, II & III without decitabine. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • G-CSF
  • Dexrazoxane
AZA+ADE | AZA+FLAG+Ida | AZA+AE | AZA+MA | AZA+Asp+AraCExperimentalPart 2 Dose Expansion with AZA - Intermediate-Risk Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and intermediate-risk Intensification I, II, and III. Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida | DAC+AE | DAC+MA | DAC+Asp+AraCExperimentalPart 2 Dose Expansion with DAC - Intermediate-Risk Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and intermediate-risk Intensifications I, II and III. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, erwinia asparaginase, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • G-CSF
  • Dexrazoxane
AZA+ADE | AZA+FLAG-Ida+Sor | AE | MA+Sor | Asp+AraC+SorExperimentalPart 1 Tolerability with AZA - High Risk (no donor) Patients are randomized to receive 5 days of single agent azacitidine as part of Induction I & II and high-risk intensifications I, II & III without azacitidine. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida+Sor | AE | MA+Sor | Asp+AraC+SorExperimentalPart 1 Tolerability with DAC - High Risk (no donor) Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and then receive high-risk Intensifications I, II & III without decitabine. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
AZA | + ADE | +FLAG+Ida+Sor| +AE | +MA+Sor | +Asp +AraC+SorExperimentalPart 2 Dose Expansion with AZA - High Risk (no donor) Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and high-risk Intensifications I, II and III. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
DAC |+ADE | +FLAG+Ida+Sor | +AE | +MA+Sor | +Asp +AraC+SorExperimentalPart 2 Dose Expansion with DAC - High Risk (no donor) Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and high-risk Intensifications I, II and III. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, sorafenib, mitoxantrone, erwinia asparaginase, ITMHA.
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
AZA+ADE | AZA+FLAG+Ida+Sor | MA+Sor | Asp+AraC+SorExperimentalPart 1 Tolerability with AZA- High Risk (with donor) Patients are randomized to receive 5 days of single agent azacitidine as part of Induction I Induction II and high-risk Intensifications I or high risk intensification III without azacitidine. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations. Interventions: azacitidine cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
DAC+ADE | DAC+FLAG+Ida+Sor | MA+Sor | Asp+AraC+SorExperimentalPart 1 Tolerability with DAC - High Risk (with donor) Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and then receive high-risk Intensifications I or high risk intensification III without decitabine. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
DAC | +ADE | +FLAG+Ida+Sor | +MA+Sor | +Asp+AraC+SorExperimentalPart 2 Dose Expansion with DAC - High Risk (with donor) Patients are randomized to receive 5 days of single agent decitabine as part of Inductions I & II and high-risk Intensifications I or high risk intensification III. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations. Interventions: decitabine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant
  • Decitabine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane
AZA | +ADE | +FLAG+Ida+Sor | +MA+Sor | +Asp+AraC+SorExperimentalPart 2 Dose Expansion with AZA - High Risk (with donor) Patients are randomized to receive 5 days of single agent azacitidine as part of Inductions I & II and high-risk Intensifications I or high risk intensification III. Patients will proceed to stem cell transplant. Sorafenib is limited to patients with FLT3-ITD+/NUP98-NSD1+ or FLT3-ITD+/WT1mut somatic mutations. Interventions: azacitidine, cytarabine, daunorubicin, etoposide, dexrazoxane, fludarabine, idarubicin, G- CSF, mitoxantrone, sorafenib, ITMHA, erwinia asparaginase, stem cell transplant.
  • Azacitidine
  • Cytarabine
  • Daunorubicin
  • Etoposide
  • Idarubicin
  • Fludarabine
  • Mitoxantrone
  • Erwinia asparaginase
  • Sorafenib
  • G-CSF
  • Dexrazoxane

Eligibility Criteria

        INCLUSION CRITERIA:

          -  Diagnostic criteria: Patients must have one of the following diagnoses:

               -  Acute myeloid leukemia fulfilling the criteria of the WHO Classification (see
                  Appendix I), or

               -  >5% but < 20% marrow myeloblasts and evidence of a clonal de novo AML genetic
                  abnormality [e.g., t(8;21), inv(16), t(9;11)], or

               -  Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic
                  sarcoma, or chloroma), with or without evidence of a leukemia process in the bone
                  marrow or peripheral blood, with confirmation of myeloid differentiation, or

               -  High grade myelodysplastic syndrome (MDS) with greater than 5% blasts, or

               -  Patients with treatment related myeloid neoplasms including AML and MDS, provided
                  their cumulative anthracycline dose has not exceeded 230 mg/m2 doxorubicin
                  equivalents.

          -  Other criteria - Patients must meet all the following criteria:

               -  Age > 28 days and < 22 years at time of study entry inclusive, and

               -  No prior therapy for this malignancy except for one dose of intrathecal therapy
                  and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one
                  week or less for hyperleukocytosis), and

               -  Written informed consent according to institutional guidelines, and

               -  Female patients of childbearing potential must have a negative pregnancy test
                  within 2 weeks prior to enrollment, and

               -  Male and female participants of reproductive potential must use an effective
                  contraceptive method during the study and for a minimum of 6 months after study
                  treatment.

        EXCLUSION CRITERIA:

          -  Down syndrome

          -  Acute promyelocytic leukemia (APL)

          -  BCR-ABL1 chronic myeloid leukemia in blast crisis (CML-BC)

          -  Juvenile myelomonocytic leukemia (JMML)

          -  Fanconi anemia (FA)

          -  Kostmann syndrome

          -  Shwachman syndrome

          -  Other bone marrow failure syndromes or low grade (<5% bone marrow blasts) MDS.

          -  Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol.

          -  Use of investigational agents within 30 days or any anticancer therapy for this
             malignancy within 2 weeks before study entry with the exception of IT therapy,
             hydroxyurea, or low-dose cytarabine as specified in the protocol document. The patient
             must have recovered from all acute toxicities from any previous therapy.

          -  Systemic fungal, bacterial, viral, or other infection not controlled (defined as
             exhibiting ongoing signs/symptoms related to the infection and without improvement,
             despite appropriate antibiotics or other treatment).

          -  Pregnant or lactating.

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results.

          -  Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as
             specified in the protocol document. The patient must have recovered from all acute
             toxicities from any previous therapy.

          -  Patients with treatment related myeloid neoplasms with cumulative anthracyclines
             greater than 230 mg/m2 doxorubicin equivalents.
      
Maximum Eligible Age:21 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of evaluable patients who tolerate five days of single agent DMTi before a standard chemotherapy combination
Time Frame:From enrollment to completion of chemotherapy (up to 8 months after start of therapy)
Safety Issue:
Description:Patients will be monitored for grade 4-5 non-hematologic toxic events during these two courses of chemotherapy. Tolerating a course is defined as completing the course without experiencing death or a grade 4 non-hematologic toxicity.

Secondary Outcome Measures

Measure:Proportion of MRD-evaluable subjects with detectable minimal residual disease after receiving five days of a single agent DMTi followed by araC+daunorubicin+etoposide.
Time Frame:MRD will be measured after completion of DMTi+araC+daunorubicin+etoposide (up to 6 weeks after the start of therapy)
Safety Issue:
Description:Flow cytometry will be used to measure minimal residual disease at diagnosis and after completion of the first course of chemotherapy.
Measure:Kaplan-Meier estimate of event-free survival
Time Frame:From diagnosis to the first of the following events: death, relapse, resistant disease, second malignancy, or last follow-up (up to 3 years after completion of therapy)
Safety Issue:
Description:Patients will be monitored for the events of interest from enrollment for at least three years. EFS will be defined as the time elapsed from enrollment to the first of the following events: death, relapse, resistant disease, or second malignancy. EFS times for subjects who have not experienced these events at the time of analysis will be censored at date of last follow-up.
Measure:Kaplan-Meier estimate of overall survival
Time Frame:From diagnosis to the first of the following events: death or last follow-up (up to 3 years after completion of therapy)
Safety Issue:
Description:Patients will be monitored for death from enrollment for at least three years. Overall survival will be defined as the time elapsed from enrollment to death. OS times for subjects who are living at the time of analysis will be censored at date of last follow-up.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:St. Jude Children's Research Hospital

Trial Keywords

  • DNA methyltransferase inhibitors
  • Acute myeloid leukemia

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