Acute Myeloid LeukemiaNCT03715621
Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
An observational study of Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 15 Oct 2021
- How long will I take part?
- 2 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with the diagnosis of AML who is going to receive an allo-geneic HSCT within 30 days
Who may be able to join
- 18 years or old;
- Clinical diagnosis of acute myeloid leukemia (AML);
- Availabe records of MICM and NGS results at diagnosis;
- Be going to receive allo-HSCT.
Who cannot join
- Active malignancy;
- Pregnant or breast feeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First affiliated Hospital of SooChow University
Suzhou, Jiangsu, 215006
Xiang Zhang, MD, 0512-67781856, lcsy2013@sina.com
Yang Xu, doctor, 0512-67781856, xuyang1020@126.com
About this study
Official title: A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, next generation sequencing, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year relapse rate after allo-HSCT
1-year relapse rate after allo-HSCT
Measured: 1 year after allo-HSCT
Secondary outcomes (2)
1-year recurrence-free survival (RFS)
1-year recurrence-free survival for AML participants
Measured: 1 year after allo-HSCT
1-year overall survival (OS)
1-year overall survival (OS) for AML participants
Measured: 1 year after allo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Depei, The First Affiliated Hospital of Soochow University
- Investigators
- Depei Wu, doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715621
- Sponsor's protocol ID
- AML-NGS-2018
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available.
PubMed 26376137Schmid C, Labopin M, Nagler A, Niederwieser D, Castagna L, Tabrizi R, Stadler M, Kuball J, Cornelissen J, Vorlicek J, Socie G, Falda M, Vindelov L, Ljungman P, Jackson G, Kroger N, Rank A, Polge E, Rocha V, Mohty M; Acute Leukaemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Treatment, risk factors, and outcome of adults with relapsed AML after reduced intensity conditioning for allogeneic stem cell transplantation. Blood. 2012 Feb 9;119(6):1599-606. doi: 10.1182/blood-2011-08-375840. Epub 2011 Dec 13.
PubMed 22167752Corbacioglu A, Scholl C, Schlenk RF, Eiwen K, Du J, Bullinger L, Frohling S, Reimer P, Rummel M, Derigs HG, Nachbaur D, Krauter J, Ganser A, Dohner H, Dohner K. Prognostic impact of minimal residual disease in CBFB-MYH11-positive acute myeloid leukemia. J Clin Oncol. 2010 Aug 10;28(23):3724-9. doi: 10.1200/JCO.2010.28.6468. Epub 2010 Jul 12.
PubMed 20625124Yin JA, O'Brien MA, Hills RK, Daly SB, Wheatley K, Burnett AK. Minimal residual disease monitoring by quantitative RT-PCR in core binding factor AML allows risk stratification and predicts relapse: results of the United Kingdom MRC AML-15 trial. Blood. 2012 Oct 4;120(14):2826-35. doi: 10.1182/blood-2012-06-435669. Epub 2012 Aug 8.
PubMed 22875911Gorello P, Cazzaniga G, Alberti F, Dell'Oro MG, Gottardi E, Specchia G, Roti G, Rosati R, Martelli MF, Diverio D, Lo Coco F, Biondi A, Saglio G, Mecucci C, Falini B. Quantitative assessment of minimal residual disease in acute myeloid leukemia carrying nucleophosmin (NPM1) gene mutations. Leukemia. 2006 Jun;20(6):1103-8. doi: 10.1038/sj.leu.2404149.
PubMed 16541144Schnittger S, Kern W, Tschulik C, Weiss T, Dicker F, Falini B, Haferlach C, Haferlach T. Minimal residual disease levels assessed by NPM1 mutation-specific RQ-PCR provide important prognostic information in AML. Blood. 2009 Sep 10;114(11):2220-31. doi: 10.1182/blood-2009-03-213389. Epub 2009 Jul 8.
PubMed 19587375Kronke J, Schlenk RF, Jensen KO, Tschurtz F, Corbacioglu A, Gaidzik VI, Paschka P, Onken S, Eiwen K, Habdank M, Spath D, Lubbert M, Wattad M, Kindler T, Salih HR, Held G, Nachbaur D, von Lilienfeld-Toal M, Germing U, Haase D, Mergenthaler HG, Krauter J, Ganser A, Gohring G, Schlegelberger B, Dohner H, Dohner K. Monitoring of minimal residual disease in NPM1-mutated acute myeloid leukemia: a study from the German-Austrian acute myeloid leukemia study group. J Clin Oncol. 2011 Jul 1;29(19):2709-16. doi: 10.1200/JCO.2011.35.0371. Epub 2011 May 9.
PubMed 21555683Shayegi N, Kramer M, Bornhauser M, Schaich M, Schetelig J, Platzbecker U, Rollig C, Heiderich C, Landt O, Ehninger G, Thiede C; Study Alliance Leukemia (SAL). The level of residual disease based on mutant NPM1 is an independent prognostic factor for relapse and survival in AML. Blood. 2013 Jul 4;122(1):83-92. doi: 10.1182/blood-2012-10-461749. Epub 2013 May 8.
PubMed 23656730Cilloni D, Messa F, Arruga F, Defilippi I, Gottardi E, Fava M, Carturan S, Catalano R, Bracco E, Messa E, Nicoli P, Diverio D, Sanz MA, Martinelli G, Lo-Coco F, Saglio G. Early prediction of treatment outcome in acute myeloid leukemia by measurement of WT1 transcript levels in peripheral blood samples collected after chemotherapy. Haematologica. 2008 Jun;93(6):921-4. doi: 10.3324/haematol.12165. Epub 2008 Apr 28.
PubMed 18443273Cilloni D, Renneville A, Hermitte F, Hills RK, Daly S, Jovanovic JV, Gottardi E, Fava M, Schnittger S, Weiss T, Izzo B, Nomdedeu J, van der Heijden A, van der Reijden BA, Jansen JH, van der Velden VH, Ommen H, Preudhomme C, Saglio G, Grimwade D. Real-time quantitative polymerase chain reaction detection of minimal residual disease by standardized WT1 assay to enhance risk stratification in acute myeloid leukemia: a European LeukemiaNet study. J Clin Oncol. 2009 Nov 1;27(31):5195-201. doi: 10.1200/JCO.2009.22.4865. Epub 2009 Sep 14.
PubMed 19752335Najima Y, Ohashi K, Kawamura M, Onozuka Y, Yamaguchi T, Akiyama H, Sakamaki H. Molecular monitoring of BAALC expression in patients with CD34-positive acute leukemia. Int J Hematol. 2010 May;91(4):636-45. doi: 10.1007/s12185-010-0550-8. Epub 2010 Apr 8.
PubMed 20376583Ostergaard M, Olesen LH, Hasle H, Kjeldsen E, Hokland P. WT1 gene expression: an excellent tool for monitoring minimal residual disease in 70% of acute myeloid leukaemia patients - results from a single-centre study. Br J Haematol. 2004 Jun;125(5):590-600. doi: 10.1111/j.1365-2141.2004.04952.x.
PubMed 15147374Kern W, Voskova D, Schoch C, Hiddemann W, Schnittger S, Haferlach T. Determination of relapse risk based on assessment of minimal residual disease during complete remission by multiparameter flow cytometry in unselected patients with acute myeloid leukemia. Blood. 2004 Nov 15;104(10):3078-85. doi: 10.1182/blood-2004-03-1036. Epub 2004 Jul 29.
PubMed 15284114Al-Mawali A, Gillis D, Lewis I. The use of receiver operating characteristic analysis for detection of minimal residual disease using five-color multiparameter flow cytometry in acute myeloid leukemia identifies patients with high risk of relapse. Cytometry B Clin Cytom. 2009 Mar;76(2):91-101. doi: 10.1002/cyto.b.20444.
PubMed 18727068Buccisano F, Maurillo L, Gattei V, Del Poeta G, Del Principe MI, Cox MC, Panetta P, Consalvo MI, Mazzone C, Neri B, Ottaviani L, Fraboni D, Tamburini A, Lo-Coco F, Amadori S, Venditti A. The kinetics of reduction of minimal residual disease impacts on duration of response and survival of patients with acute myeloid leukemia. Leukemia. 2006 Oct;20(10):1783-9. doi: 10.1038/sj.leu.2404313. Epub 2006 Jul 13.
PubMed 16838027
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
- ClinicalTrials.gov ID
- NCT03715621
- Acronym / sponsor ID
- AML-NGS-2018
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, next generation sequencing, Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 23 Oct 2018 (actual)
- 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.
Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with the diagnosis of AML who is going to receive an allo-geneic HSCT within 30 days
Key inclusion criteria (4 listed)
- 18 years or old;
- Clinical diagnosis of acute myeloid leukemia (AML);
- Availabe records of MICM and NGS results at diagnosis;
- Be going to receive allo-HSCT.
Key exclusion criteria (2 listed)
- Active malignancy;
- Pregnant or breast feeding women.
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
1-year relapse rate after allo-HSCT
Time frame: 1 year after allo-HSCT
1-year relapse rate after allo-HSCT
2 secondary outcomes
1-year recurrence-free survival (RFS)
Time frame: 1 year after allo-HSCT
1-year overall survival (OS)
Time frame: 1 year after allo-HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Background: PubMed 26376137Dohner H, Weisdorf DJ, Bloomfield CD. Acute Myeloid Leukemia. N Engl J Med. 2015 Sep 17;373(12):1136-52. doi: 10.1056/NEJMra1406184. No abstract available.
- Background: PubMed 22167752Schmid C, Labopin M, Nagler A, Niederwieser D, Castagna L, Tabrizi R, Stadler M, Kuball J, Cornelissen J, Vorlicek J, Socie G, Falda M, Vindelov L, Ljungman P, Jackson G, Kroger N, Rank A, Polge E, Rocha V, Mohty M; Acute Leukaemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Treatment, risk factors, and outcome of adults with relapsed AML after reduced intensity conditioning for allogeneic stem cell transplantation. Blood. 2012 Feb 9;119(6):1599-606. doi: 10.1182/blood-2011-08-375840. Epub 2011 Dec 13.
- Background: PubMed 20625124Corbacioglu A, Scholl C, Schlenk RF, Eiwen K, Du J, Bullinger L, Frohling S, Reimer P, Rummel M, Derigs HG, Nachbaur D, Krauter J, Ganser A, Dohner H, Dohner K. Prognostic impact of minimal residual disease in CBFB-MYH11-positive acute myeloid leukemia. J Clin Oncol. 2010 Aug 10;28(23):3724-9. doi: 10.1200/JCO.2010.28.6468. Epub 2010 Jul 12.
- Background: PubMed 22875911Yin JA, O'Brien MA, Hills RK, Daly SB, Wheatley K, Burnett AK. Minimal residual disease monitoring by quantitative RT-PCR in core binding factor AML allows risk stratification and predicts relapse: results of the United Kingdom MRC AML-15 trial. Blood. 2012 Oct 4;120(14):2826-35. doi: 10.1182/blood-2012-06-435669. Epub 2012 Aug 8.
- Background: PubMed 16541144Gorello P, Cazzaniga G, Alberti F, Dell'Oro MG, Gottardi E, Specchia G, Roti G, Rosati R, Martelli MF, Diverio D, Lo Coco F, Biondi A, Saglio G, Mecucci C, Falini B. Quantitative assessment of minimal residual disease in acute myeloid leukemia carrying nucleophosmin (NPM1) gene mutations. Leukemia. 2006 Jun;20(6):1103-8. doi: 10.1038/sj.leu.2404149.
- Background: PubMed 19587375Schnittger S, Kern W, Tschulik C, Weiss T, Dicker F, Falini B, Haferlach C, Haferlach T. Minimal residual disease levels assessed by NPM1 mutation-specific RQ-PCR provide important prognostic information in AML. Blood. 2009 Sep 10;114(11):2220-31. doi: 10.1182/blood-2009-03-213389. Epub 2009 Jul 8.
- Background: PubMed 21555683Kronke J, Schlenk RF, Jensen KO, Tschurtz F, Corbacioglu A, Gaidzik VI, Paschka P, Onken S, Eiwen K, Habdank M, Spath D, Lubbert M, Wattad M, Kindler T, Salih HR, Held G, Nachbaur D, von Lilienfeld-Toal M, Germing U, Haase D, Mergenthaler HG, Krauter J, Ganser A, Gohring G, Schlegelberger B, Dohner H, Dohner K. Monitoring of minimal residual disease in NPM1-mutated acute myeloid leukemia: a study from the German-Austrian acute myeloid leukemia study group. J Clin Oncol. 2011 Jul 1;29(19):2709-16. doi: 10.1200/JCO.2011.35.0371. Epub 2011 May 9.
- Background: PubMed 23656730Shayegi N, Kramer M, Bornhauser M, Schaich M, Schetelig J, Platzbecker U, Rollig C, Heiderich C, Landt O, Ehninger G, Thiede C; Study Alliance Leukemia (SAL). The level of residual disease based on mutant NPM1 is an independent prognostic factor for relapse and survival in AML. Blood. 2013 Jul 4;122(1):83-92. doi: 10.1182/blood-2012-10-461749. Epub 2013 May 8.
- Background: PubMed 18443273Cilloni D, Messa F, Arruga F, Defilippi I, Gottardi E, Fava M, Carturan S, Catalano R, Bracco E, Messa E, Nicoli P, Diverio D, Sanz MA, Martinelli G, Lo-Coco F, Saglio G. Early prediction of treatment outcome in acute myeloid leukemia by measurement of WT1 transcript levels in peripheral blood samples collected after chemotherapy. Haematologica. 2008 Jun;93(6):921-4. doi: 10.3324/haematol.12165. Epub 2008 Apr 28.
- Background: PubMed 19752335Cilloni D, Renneville A, Hermitte F, Hills RK, Daly S, Jovanovic JV, Gottardi E, Fava M, Schnittger S, Weiss T, Izzo B, Nomdedeu J, van der Heijden A, van der Reijden BA, Jansen JH, van der Velden VH, Ommen H, Preudhomme C, Saglio G, Grimwade D. Real-time quantitative polymerase chain reaction detection of minimal residual disease by standardized WT1 assay to enhance risk stratification in acute myeloid leukemia: a European LeukemiaNet study. J Clin Oncol. 2009 Nov 1;27(31):5195-201. doi: 10.1200/JCO.2009.22.4865. Epub 2009 Sep 14.
- Background: PubMed 20376583Najima Y, Ohashi K, Kawamura M, Onozuka Y, Yamaguchi T, Akiyama H, Sakamaki H. Molecular monitoring of BAALC expression in patients with CD34-positive acute leukemia. Int J Hematol. 2010 May;91(4):636-45. doi: 10.1007/s12185-010-0550-8. Epub 2010 Apr 8.
- Background: PubMed 15147374Ostergaard M, Olesen LH, Hasle H, Kjeldsen E, Hokland P. WT1 gene expression: an excellent tool for monitoring minimal residual disease in 70% of acute myeloid leukaemia patients - results from a single-centre study. Br J Haematol. 2004 Jun;125(5):590-600. doi: 10.1111/j.1365-2141.2004.04952.x.
- Individual participant dataSharing planned: Undecided
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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.
Depei Wu, doctor principal investigator
The First Affiliated Hospital of Soochow University
1 site 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 The First Affiliated Hospital of Soochow University at 1 site in China.
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 4 inclusion and 2 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Xiang Zhang, master (8613382108261, lcsy2013@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year relapse rate after allo-HSCT (time frame: 1 year after allo-HSCT). 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 NCT03715621, which also lists 25 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 23 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.