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

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ClinicalTrials.gov Identifier: NCT03023384
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
International Consortium on Acute Leukemias

Brief Summary:
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.

Condition or disease
Acute Myeloid Leukemia

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 547 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022





Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 2 years ]
    Time from diagnosis until relapse


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    Time from diagnosis until death from any cause


Biospecimen Retention:   Samples With DNA
Whole blood and Bone Marrow Aspirate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with Acute Myeloid Leukemia
Criteria

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%


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023384


Contacts
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Contact: Eduardo M Rego, MD +55-16-2101-9361 emrego@hcrp.usp.br
Contact: Michelle Lara (202) 776-0544 ext 4901 mlara@hematology.org

Locations
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Brazil
Hospital das Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Rosane I Bittencourt, MD       rbittencourt@hcpa.edu.br   
Principal Investigator: Rosane I Bittencourt, MD         
Hospital das Clínicas da Unicamp Recruiting
Campinas, São Paulo, Brazil
Contact: Katia BB Pagnano, MD       kborgia@unicamp.br   
Principal Investigator: Katia BB Pagnano, MD         
Hospital das Clinicas de Ribeirão Preto Recruiting
Ribeirao Preto, São Paulo, Brazil
Contact: Luisa CA Koury, MD    +55-16-98106-9709    luisa.koury.lk@gmail.com   
Sub-Investigator: Luisa CA Koury, MD         
Hospital Mario Covas Recruiting
Santo Andre, São Paulo, Brazil
Contact: Ronald S Pallotta, MD       rp.cohs@yahoo.com.br   
Principal Investigator: Ronald S Pallotta, MD         
Hospital de Base de São José do Rio Preto Recruiting
Sao Jose do Rio Preto, São Paulo, Brazil
Contact: Marcos RP Oltramari, MD       marcos.oltramari@gmail.com   
Principal Investigator: Marcos RP Oltramari, MD         
Hospital São Paulo Recruiting
Sao Paulo, São Paulo, Brazil
Contact: Thiago R Noronha, MD       thinoronha@yahoo.com.br   
Sub-Investigator: Thiago R Noronha, MD         
Sponsors and Collaborators
International Consortium on Acute Leukemias
Investigators
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Principal Investigator: Eduardo M Rego, MD University of São Paulo
Additional Information:

Publications:

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Responsible Party: International Consortium on Acute Leukemias
ClinicalTrials.gov Identifier: NCT03023384    
Other Study ID Numbers: ICAML2015
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by International Consortium on Acute Leukemias:
Acute Myeloid Leukemia
Chemotherapy
Autologous Stem Cell Transplantation
Developing country
Clinical network
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms