Leukemia, Nonlymphoblastic, AcutePhase 4NCT00180115
AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients
A Phase 4 study testing Cytarabine Dosage in people with Leukemia, Nonlymphoblastic, Acute, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia, Nonlymphoblastic, Acute
- What is being tested?
- Cytarabine Dosage
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Feb 1996to Nov 2008
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7
- de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T
- written informed consent
Who cannot join
- severe comorbidities
- severe uncontrolled complications of the leukemia
- previous therapy of leukemia/MDS
- HIV-Infection
- known relevant allergy against study medication
- pregnancy
- missing written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Department I, University Hospital Carl Gustav Carus
Dresden, 01307
About this study
Official title: AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
Read the detailed description
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
- Conditions
- Leukemia, Nonlymphoblastic, Acute
- Being tested
- Cytarabine Dosage
- Keywords
- acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation
- 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.
Cytarabine DosageDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- rate of complete remission
- overall survival
- relapse-free survival
Secondary outcomes (4)
- frequencies and grade of treatment side effects
- deaths within induction therapy
- deaths within postremission therapy
- feasibility according to dosages and time-intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 1996
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Nonlymphoblastic, AcuteStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Ehninger, MD, Principal investigator, University Hospital Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180115
- Sponsor's protocol ID
- MK1-191
- Status last verified
- Jul 2007
- First submitted
- 12 Sep 2005
- Last updated
- 17 Jul 2007
- Results posted
- No
Publications
Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
PubMed 36064577Heidrich K, Thiede C, Schafer-Eckart K, Schmitz N, Aulitzky WE, Kramer A, Rosler W, Hanel M, Einsele H, Baldus CD, Trappe RU, Stolzel F, Middeke JM, Rollig C, Taube F, Kramer M, Serve H, Berdel WE, Ehninger G, Bornhauser M, Schetelig J; Study Alliance Leukemia (SAL). Allogeneic hematopoietic cell transplantation in intermediate risk acute myeloid leukemia negative for FLT3-ITD, NPM1- or biallelic CEBPA mutations. Ann Oncol. 2017 Nov 1;28(11):2793-2798. doi: 10.1093/annonc/mdx500.
PubMed 28945881Herold T, Metzeler KH, Vosberg S, Hartmann L, Rollig C, Stolzel F, Schneider S, Hubmann M, Zellmeier E, Ksienzyk B, Jurinovic V, Pasalic Z, Kakadia PM, Dufour A, Graf A, Krebs S, Blum H, Sauerland MC, Buchner T, Berdel WE, Woermann BJ, Bornhauser M, Ehninger G, Mansmann U, Hiddemann W, Bohlander SK, Spiekermann K, Greif PA. Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis. Blood. 2014 Aug 21;124(8):1304-11. doi: 10.1182/blood-2013-12-540716. Epub 2014 Jun 12.
PubMed 24923295Rollig C, Thiede C, Gramatzki M, Aulitzky W, Bodenstein H, Bornhauser M, Platzbecker U, Stuhlmann R, Schuler U, Soucek S, Kramer M, Mohr B, Oelschlaegel U, Stolzel F, von Bonin M, Wermke M, Wandt H, Ehninger G, Schaich M; Study Alliance Leukemia. A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial. Blood. 2010 Aug 12;116(6):971-8. doi: 10.1182/blood-2010-01-267302. Epub 2010 May 4.
PubMed 20442365Wandt H, Schakel U, Kroschinsky F, Prange-Krex G, Mohr B, Thiede C, Pascheberg U, Soucek S, Schaich M, Ehninger G. MLD according to the WHO classification in AML has no correlation with age and no independent prognostic relevance as analyzed in 1766 patients. Blood. 2008 Feb 15;111(4):1855-61. doi: 10.1182/blood-2007-08-101162. Epub 2007 Dec 4.
PubMed 18056840
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.
- ClinicalTrials.gov ID
- NCT00180115
- Acronym / sponsor ID
- MK1-191
- Conditions
- Leukemia, Nonlymphoblastic, Acute
- Keywords
- acute myeloid leukemia, cytarabine postremission dosage, risk adapted treatment strategy, allogeneic stem cell transplantation, autologous stem cell transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Feb 1996
- Study completion
- Nov 2008
- First posted
- 16 Sep 2005 (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.
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
Detailed description
The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7
- de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T
- written informed consent
Key exclusion criteria (7 listed)
- severe comorbidities
- severe uncontrolled complications of the leukemia
- previous therapy of leukemia/MDS
- HIV-Infection
- known relevant allergy against study medication
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 |
|---|---|---|
| Cytarabine Dosage | Drug | – |
Primary outcome
- rate of complete remission
- overall survival
- relapse-free survival
4 secondary outcomes
- frequencies and grade of treatment side effects
- deaths within induction therapy
- deaths within postremission therapy
- feasibility according to dosages and time-intervals
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 17 Jul 2007.
- Derived from this study: PubMed 36064577Kunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.
- Derived from this study: PubMed 28945881Heidrich K, Thiede C, Schafer-Eckart K, Schmitz N, Aulitzky WE, Kramer A, Rosler W, Hanel M, Einsele H, Baldus CD, Trappe RU, Stolzel F, Middeke JM, Rollig C, Taube F, Kramer M, Serve H, Berdel WE, Ehninger G, Bornhauser M, Schetelig J; Study Alliance Leukemia (SAL). Allogeneic hematopoietic cell transplantation in intermediate risk acute myeloid leukemia negative for FLT3-ITD, NPM1- or biallelic CEBPA mutations. Ann Oncol. 2017 Nov 1;28(11):2793-2798. doi: 10.1093/annonc/mdx500.
- Derived from this study: PubMed 24923295Herold T, Metzeler KH, Vosberg S, Hartmann L, Rollig C, Stolzel F, Schneider S, Hubmann M, Zellmeier E, Ksienzyk B, Jurinovic V, Pasalic Z, Kakadia PM, Dufour A, Graf A, Krebs S, Blum H, Sauerland MC, Buchner T, Berdel WE, Woermann BJ, Bornhauser M, Ehninger G, Mansmann U, Hiddemann W, Bohlander SK, Spiekermann K, Greif PA. Isolated trisomy 13 defines a homogeneous AML subgroup with high frequency of mutations in spliceosome genes and poor prognosis. Blood. 2014 Aug 21;124(8):1304-11. doi: 10.1182/blood-2013-12-540716. Epub 2014 Jun 12.
- Derived from this study: PubMed 20442365Rollig C, Thiede C, Gramatzki M, Aulitzky W, Bodenstein H, Bornhauser M, Platzbecker U, Stuhlmann R, Schuler U, Soucek S, Kramer M, Mohr B, Oelschlaegel U, Stolzel F, von Bonin M, Wermke M, Wandt H, Ehninger G, Schaich M; Study Alliance Leukemia. A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial. Blood. 2010 Aug 12;116(6):971-8. doi: 10.1182/blood-2010-01-267302. Epub 2010 May 4.
- Derived from this study: PubMed 18056840Wandt H, Schakel U, Kroschinsky F, Prange-Krex G, Mohr B, Thiede C, Pascheberg U, Soucek S, Schaich M, Ehninger G. MLD according to the WHO classification in AML has no correlation with age and no independent prognostic relevance as analyzed in 1766 patients. Blood. 2008 Feb 15;111(4):1855-61. doi: 10.1182/blood-2007-08-101162. Epub 2007 Dec 4.
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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.
Gerhard Ehninger, MD principal investigator
University Hospital Carl Gustav Carus Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytarabine Dosage in people with Leukemia, Nonlymphoblastic, Acute, run by Technische Universität Dresden at 1 site in Germany.
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 3 inclusion and 7 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 17 Jul 2007. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
- rate of complete remission. The study lists 3 primary outcomes in all. 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 NCT00180115, which also lists 5 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 17 Jul 2007.