Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML
NCT ID: NCT03023384
Last Updated: 2017-02-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
547 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-12-31
Study Completion Date
2022-01-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Acute Myeloid Leukemia
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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%.
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%
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%
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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International Consortium on Acute Leukemias
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Eduardo M Rego, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
RECRUITING
Hospital das Clínicas da Unicamp
Campinas, São Paulo, Brazil
Site Status
RECRUITING
Hospital das Clinicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Site Status
RECRUITING
Hospital Mario Covas
Santo André, São Paulo, Brazil
Site Status
RECRUITING
Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Site Status
RECRUITING
Hospital São Paulo
São Paulo, São Paulo, Brazil
Site Status
RECRUITING
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
Vellenga E, van Putten W, Ossenkoppele GJ, Verdonck LF, Theobald M, Cornelissen JJ, Huijgens PC, Maertens J, Gratwohl A, Schaafsma R, Schanz U, Graux C, Schouten HC, Ferrant A, Bargetzi M, Fey MF, Lowenberg B; Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON); Swiss Group for Clinical Cancer Research Collaborative Group (SAKK). Autologous peripheral blood stem cell transplantation for acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6037-42. doi: 10.1182/blood-2011-07-370247. Epub 2011 Sep 27.
Reference Type
BACKGROUND
Klein JP, Andersen PK. Regression modeling of competing risks data based on pseudovalues of the cumulative incidence function. Biometrics. 2005 Mar;61(1):223-9. doi: 10.1111/j.0006-341X.2005.031209.x.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICAML2015
Identifier Type: -
Identifier Source: org_study_id
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