Acute Myeloid Leukemia (AML)Phase 2azacitidineNCT01180322
Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine
A Phase 2 study testing Cytarabine, Idarubicin and Etoposide in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 44 sites in 2 countries.
Trial summary
This is a randomized phase II, four-arm, open-label, multi-center study in adult patients with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria. The primary efficacy objective is to evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Cytarabine, Idarubicin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 44 sitesin 2 countries
- Study dates
- Nov 2010to 2 Oct 2016
- Phase
- Phase 2
- 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
Who may be able to join
- Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) classification)
- Patients considered eligible for intensive chemotherapy
- WHO performance status of ≤ 2
- Age ≥ 18 years. There is no upper age limit.
- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis
- Non-pregnant and non-nursing. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to registration. "Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
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- Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for 3 month after the last dose of chemotherapy.
- Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control.
- Men must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. (while on therapy and for 3 month after the last dose of chemotherapy)
- Signed written informed consent.
Who cannot join
- -AML with other recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
- AML with NPM1 mutation
- AML with FLT3 mutation
- Performance status WHO >2
- Patients with ejection fraction < 50% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO scan) within 14 days of day 1
- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
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- Uncontrolled infection
- Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
- Known positive for Human immunodeficiency virus (HIV)
- Bleeding disorder independent of leukemia
- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and/or other physicians involved in the treatment of the patient about study participation.
- No consent for biobanking.
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
Germany39 sites
Universitätsklinikum Charité Berlin
Berlin, 13353
Knappschaftskrankenhaus Bochum-Langendreer
Bochum, 44892
Universitätsklinikum Bonn
Bonn, 53111
Städtisches Klinikum Braunschweig
Braunschweig, 38114
Klinikum Bremen-Mitte
Bremen, 28177
Klinikum Darmstadt
Darmstadt, 64283
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Kliniken Essen Süd, Evangelischs Krankenhaus
Essen, 45239
Klinikum Esslingen
Esslingen am Neckar, 73730
Klinikum Frankfurt-Höchst
Frankfurt, 65929
Medizinisches Versorgungszentrum Fulda
Fulda, 36043
Universitätsklinikum Gießen
Giessen, 35392
Wilhelm-Anton-Hospital Goch
Goch, 47574
Universitätsklinikum Göttingen
Göttingen, 37075
Sklepios Klinik Hamburg-Altona
Hamburg, 22763
Evangelisches Krankenhaus Hamm
Hamm, 59063
Klinikum Hanau
Hanau, 63450
KRH Klinikum Hannover-Siloah
Hanover, 30449
Medizinische Hochschule Hannover
Hanover, 30625
SLK-Kliniken Heilbronn
Heilbronn, 74078
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Universitätsklinikum Schleswig-Holstein
Kiel, 24116
Caritas-Krankenhaus Lebach
Lebach, 66822
Klinikum Lippe
Lemgo, 32657
Klinikum Lüdenscheid
Lüdenscheid, 58515
Klinikum der Johannes-Guttenberg-Universität
Mainz, 55131
Johannes Wesling Klinikum Minden
Minden, 32429
Klinikum rechts der Isar
München, 81675
Stauferklinikum Schwäbisch-Gmünd
Mutlangen, 73557
Klinikum Passau
Passau, 94032
Krankenhaus der Barmherzigen Brüder
Regensburg, 93049
Caritas-Klinik St. Theresia
Saarbrücken, 66113
Klinikum Stuttgart
Stuttgart, 70174
Diakonie-Klinikum Stuttgart
Stuttgart, 70176
Krankenhaus der Barmherzigen Brüder
Trier, 54292
Universitätsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, 78050
Helios Klinikum
Wuppertal, 42283
Austria5 sites
Universitätsklinikum Innsbruck
Innsbruck, 6020
Krankenhaus der Barmherzigen Schwestern
Linz, 4010
Elisabethinen Krankenhaus Linz
Linz, 4020
Landeskliniken Salzburg
Salzburg, 5020
Hanuschkrankenhaus
Vienna, 1140
About this study
Official title: Randomized Phase-II Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine
This is a randomized phase II, four-arm, open-label, multi-center study in adult patients with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria.
The primary efficacy objective is to evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the complete remission (CR) rate
Read more
Sample size: 336 patients
The treatment duration of an individual patient randomized into one of the three experimental arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance therapy with Azacitidine) is about 30 months.
The treatment duration for patients randomized into the standard arm of the study (Arm A) is about 7 months (in case of application of induction, consolidation and 2-yrs observation as maintenance (without treatment with Azacitidine)).
In case of induction followed by consolidation with allogeneic Stem cell transplantation (SCT) the treatment duration per patient is about 6 months.
Every patient will be followed until month 54 after inclusion into the study. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and follow-up period: 54 months
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Cytarabine, Idarubicin, Etoposide, Azacitidine, Lenograstim
- Keywords
- azacitidine, Acute myeloid Leukemia (AML)
- 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.
CytarabineDrug
Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)
Consolidation therapy:
Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).
Elderly patients (>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).
IdarubicinDrug
First induction therapy:
Arm A, C, D:
12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.
Arm B:
12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.
Second induction therapy:
Arm A, C, D:
12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)
Arm B:
12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).
EtoposideDrug
Induction therapy:
Arm A, C, D:
100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.
Arm B:
100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 6+8.
AzacitidineDrug
Induction therapy:
Arm B and C:
100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.
Arm D:
100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.
Maintenance therapy:
Arm B, C, D:
50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR)
LenograstimDrug
Consolidation therapy:
subcutaneously daily beginning on day 10 until neutrophil count > 0.5 x 109/l.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Standard Therapy Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: Lenograstim |
| Arm B | Experimental | Investigational Therapy "Azacitidine Prior" Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: Azacitidine; Drug: Lenograstim |
| Arm C | Experimental | Investigational Therapy "Azacitidine Concurrent" Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: Azacitidine; Drug: Lenograstim |
| Arm D | Experimental | Investigational Therapy "Azacitidine After" Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Etoposide; Drug: Azacitidine; Drug: Lenograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of complete remission (CR) after induction therapy
To evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the CR rate
Measured: 56 days
Secondary outcomes (13)
Event-free survival
Measured: after two years of follow-up
Relapse-free survival
Measured: after two years of follow-up
overall survival
Measured: after two years of follow-up
days in hospital during each cycle and during the whole intervention
Measured: 6 months
Rate of early deaths or hypoplastic deaths (ED/HD)
Measured: 56 days
type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 3.0), timing and relatedness of non-hematological toxicity observed during different treatment cycles
Measured: 6 months
quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30)
quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [35].
Measured: at the end of therapy (in average 6 months) and once a year in the follow-up
duration of leukopenia after each consolidation cycle
Measured: 42 days
duration of neutropenia after each consolidation cycle
Measured: 42 days
duration of thrombocytopenia after each consolidation cycle
Measured: 42 days
duration of leukopenia after each induction cycle
Measured: 28 days
duration of neutropenia after each induction cycle
Measured: 28 days
duration of thrombocytopenia after each induction cycle
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completion2 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Richard Schlenk, University of Ulm
- Investigators
- Richard F Schlenk, MD, Principal investigator, University Hospital of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180322
- Sponsor's protocol ID
- AMLSG 12-09
- Acronym
- azacitidine
- Status last verified
- Dec 2020
- First submitted
- 2 Aug 2010
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmutz M, Zucknick M, Schlenk RF, Mertens D, Benner A, Weichenhan D, Mucke O, Dohner K, Plass C, Bullinger L, Claus R. Predictive value of DNA methylation patterns in AML patients treated with an azacytidine containing induction regimen. Clin Epigenetics. 2023 Oct 26;15(1):171. doi: 10.1186/s13148-023-01580-z.
PubMed 37885041
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase-II Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine
- ClinicalTrials.gov ID
- NCT01180322
- Acronym / sponsor ID
- azacitidine / AMLSG 12-09
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- azacitidine, Acute myeloid Leukemia (AML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- 2 Oct 2016 (actual)
- First posted
- 12 Aug 2010 (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.
This is a randomized phase II, four-arm, open-label, multi-center study in adult patients with acute myeloid leukemia (AML) as defined in inclusion/exclusion criteria.
The primary efficacy objective is to evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the complete remission (CR) rate
Sample size: 336 patients
The treatment duration of an individual patient randomized into one of the three experimental arms (Arm B, C, D) (in case of application of induction, consolidation and maintenance therapy with Azacitidine) is about 30 months.
The treatment duration for patients randomized into the standard arm of the study (Arm A) is about 7 months (in case of application of induction, consolidation and 2-yrs observation as maintenance (without treatment with Azacitidine)).
In case of induction followed by consolidation with allogeneic Stem cell transplantation (SCT) the treatment duration per patient is about 6 months.
Every patient will be followed until month 54 after inclusion into the study. Duration of the study for an individual patient including treatment (induction, consolidation [chemotherapy or allogeneic SCT], maintenance [experimental arm with Azacitidine or observation]) and follow-up period: 54 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: LenograstimStandard Therapy |
| Arm B | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: Azacitidine, Drug: LenograstimInvestigational Therapy "Azacitidine Prior" |
| Arm C | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: Azacitidine, Drug: LenograstimInvestigational Therapy "Azacitidine Concurrent" |
| Arm D | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Etoposide, Drug: Azacitidine, Drug: LenograstimInvestigational Therapy "Azacitidine After" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) classification)
- Patients considered eligible for intensive chemotherapy
- WHO performance status of ≤ 2
- Age ≥ 18 years. There is no upper age limit.
- No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis
Key exclusion criteria (13 listed)
- -AML with other recurrent genetic abnormalities (according to WHO 2008): AML with t(8;21)(q22;q22); RUNX1-RUNX1T1 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 AML with t(15;17)(q22;q12); PML-RARA (or variant translocations with other RARA gene fusions)
- AML with NPM1 mutation
- AML with FLT3 mutation
- Performance status WHO >2
- Patients with ejection fraction < 50% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO scan) within 14 days of day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytarabineInduction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2) Consolidation therapy: Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2). Elderly patients (>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2). | Drug | Arm A, Arm B, Arm C, Arm D |
| IdarubicinFirst induction therapy: Arm A, C, D: 12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3. Arm B: 12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8. Second induction therapy: Arm A, C, D: 12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups) Arm B: 12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups). | Drug | Arm A, Arm B, Arm C, Arm D |
| EtoposideInduction therapy: Arm A, C, D: 100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 1+3. Arm B: 100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 6+8. | Drug | Arm A, Arm B, Arm C, Arm D |
| AzacitidineInduction therapy: Arm B and C: 100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide. Arm D: 100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide. Maintenance therapy: Arm B, C, D: 50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR) | Drug | Arm B, Arm C, Arm D |
| LenograstimConsolidation therapy: subcutaneously daily beginning on day 10 until neutrophil count > 0.5 x 109/l. | Drug | Arm A, Arm B, Arm C, Arm D |
Primary outcome
Rates of complete remission (CR) after induction therapy
Time frame: 56 days
To evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the CR rate
13 secondary outcomes
Event-free survival
Time frame: after two years of follow-up
Relapse-free survival
Time frame: after two years of follow-up
overall survival
Time frame: after two years of follow-up
days in hospital during each cycle and during the whole intervention
Time frame: 6 months
Rate of early deaths or hypoplastic deaths (ED/HD)
Time frame: 56 days
type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 3.0), timing and relatedness of non-hematological toxicity observed during different treatment cycles
Time frame: 6 months
quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30)
Time frame: at the end of therapy (in average 6 months) and once a year in the follow-up
duration of leukopenia after each consolidation cycle
Time frame: 42 days
duration of neutropenia after each consolidation cycle
Time frame: 42 days
duration of thrombocytopenia after each consolidation cycle
Time frame: 42 days
duration of leukopenia after each induction cycle
Time frame: 28 days
duration of neutropenia after each induction cycle
Time frame: 28 days
duration of thrombocytopenia after each induction cycle
Time frame: 28 days
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 31 Dec 2020.
- Derived from this study: PubMed 37885041Schmutz M, Zucknick M, Schlenk RF, Mertens D, Benner A, Weichenhan D, Mucke O, Dohner K, Plass C, Bullinger L, Claus R. Predictive value of DNA methylation patterns in AML patients treated with an azacytidine containing induction regimen. Clin Epigenetics. 2023 Oct 26;15(1):171. doi: 10.1186/s13148-023-01580-z.
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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.
Richard F Schlenk, MD principal investigator
University Hospital of Ulm
44 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytarabine, Idarubicin and Etoposide in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 44 sites in 2 countries.
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 10 inclusion and 13 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Germany, Austria. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rates of complete remission (CR) after induction therapy (time frame: 56 days). 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 NCT01180322, which also lists 1 linked publication.
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 31 Dec 2020.