Acute Myeloid LeukemiaSIRANCT02867891
Sorafenib In Relapse of FMS-like Tyrosine Kinase 3 (FLT3)-Internal Tandem Duplication (ITD) AML Trial
An observational study of Acute Myeloid Leukemia, run by Robert Zeiser.
Trial summary
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse 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
- 396 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Dec 2016
- 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: Patients with relapse of FLT3-ITD AML after allogeneic hematopoietic stem cell transplantation
Who may be able to join
- Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT
- Age ≥18 years
- Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI
- Written informed consent
- Ability to understand the nature of the study and the study related procedures and to comply with them
Who cannot join
- Age < 18 years
- Lack of informed consent
- Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group
About this study
Official title: Multicenter, Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions (DLI) Versus Best Available Treatment (BAT) in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT.
Read the detailed description
The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- FLT3-ITD, AML, allo-HSCT
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy alone | The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Chemotherapy/DLI | The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Sorafenib alone | The specific interventions to the subjects of the study are assigned by the individual transplant center | |
| Sorafenib/DLI | The specific interventions to the subjects of the study are assigned by the individual transplant center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.
Measured: 10 years
Secondary outcomes (3)
Overall survival (OS) of the participants
Measured: 10 years
Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants.
Measured: 10 years
Number of participants with acute graft-versus-host disease (GvHD).
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startMar 2001
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Zeiser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Zeiser, University of Freiburg
- Investigators
- Robert Zeiser, Prof. Dr., Principal investigator, Medical Center University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867891
- Sponsor's protocol ID
- SIRA
- Acronym
- SIRA
- Status last verified
- Jan 2017
- First submitted
- 10 Aug 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Gotze K, Linn YC, Kroger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Muller L, Giagounidis A, Meyer RG, Brugger W, Vohringer M, Dreger P, Mori M, Basara N, Schafer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. Epub 2012 Apr 16.
PubMed 22504140De Freitas T, Marktel S, Piemontese S, Carrabba MG, Tresoldi C, Messina C, Lupo Stanghellini MT, Assanelli A, Corti C, Bernardi M, Peccatori J, Vago L, Ciceri F. High rate of hematological responses to sorafenib in FLT3-ITD acute myeloid leukemia relapsed after allogeneic hematopoietic stem cell transplantation. Eur J Haematol. 2016 Jun;96(6):629-36. doi: 10.1111/ejh.12647. Epub 2015 Sep 21.
PubMed 26260140
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Observational Trial to Determine the Response Rate of Sorafenib and Donor Lymphocyte Infusions (DLI) Versus Best Available Treatment (BAT) in FLT3-ITD-mutant AML Relapse After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02867891
- Acronym / sponsor ID
- SIRA / SIRA
- Conditions
- Acute Myeloid Leukemia
- Keywords
- FLT3-ITD, AML, allo-HSCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Robert ZeiserUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Aug 2016 (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.
In this trial the investigators will evaluate the outcomes of 4 pre-defined groups of individuals according to the therapeutic intervention. The investigators will determine the outcome of each group by monitoring the survival and the response rates of patients with FLT3-ITD AML relapse after allo-HSCT.
Detailed description
The preliminary data of the investigators demonstrate potent activity of Sorafenib combined with Donor lymphocyte infusions (DLI) in relapse of FLT3-ITD+ Acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HSCT). The investigators therefore launched an observational multicenter trial. The outcomes are assessed in 4 pre-defined groups of individuals according to the therapeutic intervention (chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group). The specific interventions to the subjects of the study are assigned by the individual transplant center. The investigators will determine the outcome of each group by monitoring the survival and the response rates (complete remission, disease burden reduction, no response) of patients with FLT3-ITD AML relapse after allo-HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy alone | – | –The specific interventions to the subjects of the study are assigned by the individual transplant center |
| Chemotherapy/DLI | – | –The specific interventions to the subjects of the study are assigned by the individual transplant center |
| Sorafenib alone | – | –The specific interventions to the subjects of the study are assigned by the individual transplant center |
| Sorafenib/DLI | – | –The specific interventions to the subjects of the study are assigned by the individual transplant center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapse of FLT3-ITD AML after allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (5 listed)
- Histology/PCR proven relapse of FLT3-ITD+ AML after allo-HSCT
- Age ≥18 years
- Treatment with either chemotherapy-alone, chemotherapy/DLI, sorafenib alone or sorafenib/DLI
- Written informed consent
- Ability to understand the nature of the study and the study related procedures and to comply with them
Key exclusion criteria (3 listed)
- Age < 18 years
- Lack of informed consent
- Patients that cannot be classified in one of the 4 groups: chemotherapy-alone-group, chemotherapy/DLI group, sorafenib alone group and sorafenib/DLI group
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
Response to treatment
Time frame: 10 years
The primary endpoint is response to treatment, defined as the number of participants that archive a complete remission.
3 secondary outcomes
Overall survival (OS) of the participants
Time frame: 10 years
Serum cytokine levels (Interleukin (IL)-15, Interferon-gamma, IL-6) of the participants.
Time frame: 10 years
Number of participants with acute graft-versus-host disease (GvHD).
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Background: PubMed 22504140Metzelder SK, Schroeder T, Finck A, Scholl S, Fey M, Gotze K, Linn YC, Kroger M, Reiter A, Salih HR, Heinicke T, Stuhlmann R, Muller L, Giagounidis A, Meyer RG, Brugger W, Vohringer M, Dreger P, Mori M, Basara N, Schafer-Eckart K, Schultheis B, Baldus C, Neubauer A, Burchert A. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia. 2012 Nov;26(11):2353-9. doi: 10.1038/leu.2012.105. Epub 2012 Apr 16.
- Background: PubMed 26260140De Freitas T, Marktel S, Piemontese S, Carrabba MG, Tresoldi C, Messina C, Lupo Stanghellini MT, Assanelli A, Corti C, Bernardi M, Peccatori J, Vago L, Ciceri F. High rate of hematological responses to sorafenib in FLT3-ITD acute myeloid leukemia relapsed after allogeneic hematopoietic stem cell transplantation. Eur J Haematol. 2016 Jun;96(6):629-36. doi: 10.1111/ejh.12647. Epub 2015 Sep 21.
- Individual participant dataSharing planned: No
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Robert Zeiser, Prof. Dr. principal investigator
Medical Center University of Freiburg
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Robert Zeiser.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: 10 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 NCT02867891, which also lists 2 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 18 Jan 2017.