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

Sponsor

International Consortium on Acute Leukemias (Other)

Overall Status

Unknown status

CT.gov ID

NCT03023384

Collaborator

(none)

547

Enrollment

Locations

Duration (Months)

91.2

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Acute Myeloid Leukemia

Detailed Description

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.
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.
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
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;
Develop a method of assessing minimal residual disease based on flow cytometry adapted to local resources and capable of guiding therapeutic decisions;
Determine the time interval between: a) diagnosis and risk group determination; b) the first cycle of consolidation chemotherapy and autologous hematopoietic stem cells infusion;
Determine the frequency and etiologic agent of infections associated with treatment, the number and average duration of hospitalization due to episodes of neutropenia;
Create a bank of samples of bone marrow from AML patients at different times of treatment;
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

547 participants

Observational Model:

Other

Time Perspective:

Prospective

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 :

Dec 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Outcome Measures

Primary Outcome Measures

Disease free survival [2 years]
Time from diagnosis until relapse

Secondary Outcome Measures

Overall survival [2 years]
Time from diagnosis until death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Suitable cardiac function: left ventricular ejection fraction ≥ 50%.

Exclusion Criteria:

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

Altered cardiac function, with LVEF <50%

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital das Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Brazil
2	Hospital das Clínicas da Unicamp	Campinas	São Paulo	Brazil
3	Hospital das Clinicas de Ribeirão Preto	Ribeirao Preto	São Paulo	Brazil
4	Hospital Mario Covas	Santo Andre	São Paulo	Brazil
5	Hospital de Base de São José do Rio Preto	Sao Jose do Rio Preto	São Paulo	Brazil
6	Hospital São Paulo	Sao Paulo	São Paulo	Brazil