Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML (ICAML2015)

February 1, 2017 updated by: International Consortium on Acute Leukemias

Feasibility Study of the Use of Intermediate Doses of Cytarabine Associated With Autologous Hematopoietic Stem Cells as Consolidation Treatment of Young Adults With Low- or Intermediate-risk de Novo Acute Myeloid Leukemia

Create a network of institutions in developing countries that will perform AML diagnosis, risk classification, treatment, supportive care and follow-up evaluation according to a common protocol and will register data using common clinical research forms (CRFs) in a single database and available on the internet.

Study Overview

Status

Unknown

Conditions

Detailed Description

  1. Compare overall survival and disease-free survival of patients with acute myeloid leukemia classified according the European LeukemiaNet treated in participating South American hospitals with the results reported in developed countries.
  2. Compare overall survival and disease-free survival of patients with AML low or intermediate risk treated with two cycles of cytarabine in intermediate dose versus one cytarabine cycle at the same dose followed by autologous SCT as consolidation. The risk will be established according to the classification of the European LeukemiaNet.
  3. Create a network of institutions in developing countries that will perform AML diagnosis, risk classification, treatment, supportive care and follow-up evaluation according to a common protocol and will register data using common clinical research forms (CRFs) in a single database and available on the internet
  4. Using National Reference Laboratories, provide cytogenetic and molecular methods for all institutions participating in the network, thus allowing rapid diagnosis and risk stratification of AML cases according to the European LeukemiaNet structure;
  5. Develop a method of assessing minimal residual disease based on flow cytometry adapted to local resources and capable of guiding therapeutic decisions;
  6. Determine the time interval between: a) diagnosis and risk group determination; b) the first cycle of consolidation chemotherapy and autologous hematopoietic stem cells infusion;
  7. Determine the frequency and etiologic agent of infections associated with treatment, the number and average duration of hospitalization due to episodes of neutropenia;
  8. Create a bank of samples of bone marrow from AML patients at different times of treatment;
  9. Determine the disease-free survival and the cumulative incidence rate of relapse and non-relapse mortality and compare them between chemotherapy alone and chemotherapy plus autologous SCT cohorts.

Study Type

Observational

Enrollment (Anticipated)

547

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Recruiting
        • Hospital das Clinicas de Porto Alegre
        • Contact:
        • Principal Investigator:
          • Rosane I Bittencourt, MD
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Recruiting
        • Hospital das Clínicas da Unicamp
        • Contact:
        • Principal Investigator:
          • Katia BB Pagnano, MD
      • Ribeirao Preto, São Paulo, Brazil
        • Recruiting
        • Hospital das Clinicas de Ribeirao Preto
        • Contact:
        • Sub-Investigator:
          • Luisa CA Koury, MD
      • Santo Andre, São Paulo, Brazil
        • Recruiting
        • Hospital Mario Covas
        • Contact:
        • Principal Investigator:
          • Ronald S Pallotta, MD
      • Sao Jose do Rio Preto, São Paulo, Brazil
        • Recruiting
        • Hospital de Base de Sao Jose do Rio Preto
        • Contact:
        • Principal Investigator:
          • Marcos RP Oltramari, MD
      • Sao Paulo, São Paulo, Brazil
        • Recruiting
        • Hospital Sao Paulo
        • Contact:
        • Sub-Investigator:
          • Thiago R Noronha, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with Acute Myeloid Leukemia

Description

Inclusion Criteria:

  1. Acute myeloid leukemia (AML) diagnosis according to WHO criteria;
  2. AML not treated previously, including: de novo AML or secondary to myelodysplastic syndromes;
  3. Absence of t(15;17), or PML-RARA rearrangement and its variants (acute promyelocytic leukemia diagnosis);
  4. Age greater than or equal to 18 years old or lower than or equal to 65 years old;
  5. Functional status ECOG from 0 to 2;
  6. Signed informed consent;
  7. Ability to follow the protocol procedures;
  8. Willingness to use birth control methods during the treatment until its conclusion;

  9. Adequate renal and liver function:

    • Bilirubin ≤ 1.5x the upper limit of normality;
    • AST and ALT ≤ 2.5x the upper limit of normality;
    • Creatinine ≤ 2.5 mg/dL.
  10. Suitable cardiac function: left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

  1. Acute promyelocytic leukemia (APL) diagnosis according to WHO criteria;
  2. Diagnosis of acute leukemia of ambiguous lineage, biphenotypic acute leukemia or undifferentiated acute leukemia, according to WHO criteria;
  3. AML previously treated, except with hydroxyurea administration for cytoreduction;
  4. Age greater than 65 years old or lower than 18 years old;
  5. Functional status ECOG greater than 2;
  6. Do not sign the informed consent;
  7. Inability to follow the protocol procedures;
  8. Be fertile female who are unwilling to take any birth control method during the treatment;
  9. Hypersensitivity to any drug of the treatment protocol;
  10. Positive serology for HIV;

  11. Altered liver and renal function not related to the primary disease (AML):

    • Bilirubin > 1.5x the upper limit of normality
    • AST and ALT > the 2.5x upper limit of normality
    • Creatinine > 2.5 mg/dL

n) Altered cardiac function, with LVEF <50%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 2 years
Time from diagnosis until relapse
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Time from diagnosis until death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Consortium on Acute Leukemias

Investigators

  • Principal Investigator: Eduardo M Rego, MD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICAML2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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