Acute Myeloid LeukemiaICAML2015NCT03023384
Feasibility Study of Intermediate Doses of ARA-C With Autologous SCT as Consolidation of Low/Intermediate-risk AML
An observational study of Acute Myeloid Leukemia, run by International Consortium on Acute Leukemias at 6 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 547 participants
- Where
- 6 sitesBrazil
- Study dates
- Dec 2016to Jan 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Acute Myeloid Leukemia
Who may be able to join
- 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;
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- 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%.
Who cannot join
- 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;
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- 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%
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites, 6 recruiting
- Recruiting
Hospital das Clínicas da Unicamp
Campinas, São Paulo
Katia BB Pagnano, MD, kborgia@unicamp.br
Katia BB Pagnano, MD
- Recruiting
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Rosane I Bittencourt, MD, rbittencourt@hcpa.edu.br
Rosane I Bittencourt, MD
- Recruiting
Hospital das Clinicas de Ribeirão Preto
Ribeirão Preto, São Paulo
Luisa CA Koury, MD, +55-16-98106-9709, luisa.koury.lk@gmail.com
Luisa CA Koury, MD
- Recruiting
Hospital Mario Covas
Santo André, São Paulo
Ronald S Pallotta, MD, rp.cohs@yahoo.com.br
Ronald S Pallotta, MD
- Recruiting
Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo
Marcos RP Oltramari, MD, marcos.oltramari@gmail.com
Marcos RP Oltramari, MD
- Recruiting
Hospital São Paulo
São Paulo, São Paulo
Thiago R Noronha, MD, thinoronha@yahoo.com.br
Thiago R Noronha, MD
About this study
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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Chemotherapy, Autologous Stem Cell Transplantation, Developing country, Clinical network
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Time from diagnosis until relapse
Measured: 2 years
Secondary outcomes (1)
Overall survival
Time from diagnosis until death from any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 547 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- International Consortium on Acute Leukemias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo M Rego, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023384
- Sponsor's protocol ID
- ICAML2015
- Acronym
- ICAML2015
- Status last verified
- Feb 2017
- First submitted
- 13 Jan 2017
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011 Feb 10;29(5):487-94. doi: 10.1200/JCO.2010.30.1820. Epub 2011 Jan 10.
PubMed 21220605Lowenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999 Sep 30;341(14):1051-62. doi: 10.1056/NEJM199909303411407. No abstract available.
PubMed 10502596Lowenberg B. Sense and nonsense of high-dose cytarabine for acute myeloid leukemia. Blood. 2013 Jan 3;121(1):26-8. doi: 10.1182/blood-2012-07-444851.
PubMed 23287624Lowenberg B, Pabst T, Vellenga E, van Putten W, Schouten HC, Graux C, Ferrant A, Sonneveld P, Biemond BJ, Gratwohl A, de Greef GE, Verdonck LF, Schaafsma MR, Gregor M, Theobald M, Schanz U, Maertens J, Ossenkoppele GJ; Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) Collaborative Group. Cytarabine dose for acute myeloid leukemia. N Engl J Med. 2011 Mar 17;364(11):1027-36. doi: 10.1056/NEJMoa1010222.
PubMed 21410371Mrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17.
PubMed 22987078Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.
PubMed 22965967Pfirrmann M, Ehninger G, Thiede C, Bornhauser M, Kramer M, Rollig C, Hasford J, Schaich M; Study Alliance Leukaemia (SAL). Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial. Lancet Oncol. 2012 Feb;13(2):207-14. doi: 10.1016/S1470-2045(11)70326-6. Epub 2011 Dec 22.
PubMed 22197676Grimwade D. The changing paradigm of prognostic factors in acute myeloid leukaemia. Best Pract Res Clin Haematol. 2012 Dec;25(4):419-25. doi: 10.1016/j.beha.2012.10.004. Epub 2012 Nov 4.
PubMed 23200538Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.
PubMed 19880497Rollig C, Bornhauser M, Thiede C, Taube F, Kramer M, Mohr B, Aulitzky W, Bodenstein H, Tischler HJ, Stuhlmann R, Schuler U, Stolzel F, von Bonin M, Wandt H, Schafer-Eckart K, Schaich M, Ehninger G. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol. 2011 Jul 10;29(20):2758-65. doi: 10.1200/JCO.2010.32.8500. Epub 2011 May 31.
PubMed 21632498Burnett AK, Wheatley K, Goldstone AH, Stevens RF, Hann IM, Rees JH, Harrison G; Medical Research Council Adult and Paediatric Working Parties. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002 Aug;118(2):385-400. doi: 10.1046/j.1365-2141.2002.03724.x.
PubMed 12139722Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, Wadleigh M, DeAngelo DJ, Stone RM, Sakamaki H, Appelbaum FR, Dohner H, Antin JH, Soiffer RJ, Cutler C. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009 Jun 10;301(22):2349-61. doi: 10.1001/jama.2009.813.
PubMed 19509382Majhail NS, Bajorunaite R, Lazarus HM, Wang Z, Klein JP, Zhang MJ, Rizzo JD. High probability of long-term survival in 2-year survivors of autologous hematopoietic cell transplantation for AML in first or second CR. Bone Marrow Transplant. 2011 Mar;46(3):385-92. doi: 10.1038/bmt.2010.115. Epub 2010 May 17.
PubMed 20479710Nakasone H, Izutsu K, Wakita S, Yamaguchi H, Muramatsu-Kida M, Usuki K. Autologous stem cell transplantation with PCR-negative graft would be associated with a favorable outcome in core-binding factor acute myeloid leukemia. Biol Blood Marrow Transplant. 2008 Nov;14(11):1262-9. doi: 10.1016/j.bbmt.2008.08.012.
PubMed 18940681Breems DA, Boogaerts MA, Dekker AW, Van Putten WL, Sonneveld P, Huijgens PC, Van der Lelie J, Vellenga E, Gratwohl A, Verhoef GE, Verdonck LF, Lowenberg B. Autologous bone marrow transplantation as consolidation therapy in the treatment of adult patients under 60 years with acute myeloid leukaemia in first complete remission: a prospective randomized Dutch-Belgian Haemato-Oncology Co-operative Group (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) trial. Br J Haematol. 2005 Jan;128(1):59-65. doi: 10.1111/j.1365-2141.2004.05282.x.
PubMed 15606550
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03023384
- Acronym / sponsor ID
- ICAML2015 / ICAML2015
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Chemotherapy, Autologous Stem Cell Transplantation, Developing country, Clinical network
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 547 participants (estimated)
- Lead sponsor
- International Consortium on Acute LeukemiasUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Acute Myeloid Leukemia
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease free survival
Time frame: 2 years
Time from diagnosis until relapse
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 21220605Burnett A, Wetzler M, Lowenberg B. Therapeutic advances in acute myeloid leukemia. J Clin Oncol. 2011 Feb 10;29(5):487-94. doi: 10.1200/JCO.2010.30.1820. Epub 2011 Jan 10.
- Background: PubMed 10502596Lowenberg B, Downing JR, Burnett A. Acute myeloid leukemia. N Engl J Med. 1999 Sep 30;341(14):1051-62. doi: 10.1056/NEJM199909303411407. No abstract available.
- Background: PubMed 23287624Lowenberg B. Sense and nonsense of high-dose cytarabine for acute myeloid leukemia. Blood. 2013 Jan 3;121(1):26-8. doi: 10.1182/blood-2012-07-444851.
- Background: PubMed 21410371Lowenberg B, Pabst T, Vellenga E, van Putten W, Schouten HC, Graux C, Ferrant A, Sonneveld P, Biemond BJ, Gratwohl A, de Greef GE, Verdonck LF, Schaafsma MR, Gregor M, Theobald M, Schanz U, Maertens J, Ossenkoppele GJ; Dutch-Belgian Cooperative Trial Group for Hemato-Oncology (HOVON) and Swiss Group for Clinical Cancer Research (SAKK) Collaborative Group. Cytarabine dose for acute myeloid leukemia. N Engl J Med. 2011 Mar 17;364(11):1027-36. doi: 10.1056/NEJMoa1010222.
- Background: PubMed 22987078Mrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17.
- Background: PubMed 22965967Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.
- Background: PubMed 22197676Pfirrmann M, Ehninger G, Thiede C, Bornhauser M, Kramer M, Rollig C, Hasford J, Schaich M; Study Alliance Leukaemia (SAL). Prediction of post-remission survival in acute myeloid leukaemia: a post-hoc analysis of the AML96 trial. Lancet Oncol. 2012 Feb;13(2):207-14. doi: 10.1016/S1470-2045(11)70326-6. Epub 2011 Dec 22.
- Background: PubMed 23200538Grimwade D. The changing paradigm of prognostic factors in acute myeloid leukaemia. Best Pract Res Clin Haematol. 2012 Dec;25(4):419-25. doi: 10.1016/j.beha.2012.10.004. Epub 2012 Nov 4.
- Background: PubMed 19880497Dohner H, Estey EH, Amadori S, Appelbaum FR, Buchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Lowenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. doi: 10.1182/blood-2009-07-235358. Epub 2009 Oct 30.
- Background: PubMed 21632498Rollig C, Bornhauser M, Thiede C, Taube F, Kramer M, Mohr B, Aulitzky W, Bodenstein H, Tischler HJ, Stuhlmann R, Schuler U, Stolzel F, von Bonin M, Wandt H, Schafer-Eckart K, Schaich M, Ehninger G. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol. 2011 Jul 10;29(20):2758-65. doi: 10.1200/JCO.2010.32.8500. Epub 2011 May 31.
- Background: PubMed 12139722Burnett AK, Wheatley K, Goldstone AH, Stevens RF, Hann IM, Rees JH, Harrison G; Medical Research Council Adult and Paediatric Working Parties. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol. 2002 Aug;118(2):385-400. doi: 10.1046/j.1365-2141.2002.03724.x.
- Background: PubMed 19509382Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, Wadleigh M, DeAngelo DJ, Stone RM, Sakamaki H, Appelbaum FR, Dohner H, Antin JH, Soiffer RJ, Cutler C. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009 Jun 10;301(22):2349-61. doi: 10.1001/jama.2009.813.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo M Rego, MD principal investigator
University of Sao Paulo
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by International Consortium on Acute Leukemias at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo M Rego, MD (+55-16-2101-9361, emrego@hcrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023384, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.