Acute Myeloid LeukaemiaPhase 3AML2004NCT01497002
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
A Phase 3 study testing Cytarabine and human stem cells in people with Acute Myeloid Leukaemia, run by University of Leipzig at 1 site in Germany.
Trial summary
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukaemia
- What is being tested?
- Cytarabine and human stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,222 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to 18 Jul 2018
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
- written informed consent
Who cannot join
- pretreatment of leukemia
- no informed consent
- simultaneous inclusion in other studies
- mental disability
- contraindication for intensive chemotherapy
- AML FAB M3
Show all 18Show fewer
- contraindication for allogeneic stem cell transplantation
- restriction of following organ functions:
- creatinine-clearance < 50 ml/min
- cardiac ejection fraction < 40 %
- severe pulmonary restriction
- bilirubin > 2x ULN; SGOT and SGPT > 4x ULN
- uncontrolled hypertension
- severe uncontrolled metabolism disturbance
- Karnofsky-performance-score < 70%
- hepatitis C
- other malignancy
- age of unrelated donor >70 years and age of related donor >75 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Read the detailed description
Measuring EFS depending on induction therapy
- Conditions
- Acute Myeloid Leukaemia
- Being tested
- Cytarabine, human stem cells
- Keywords
- 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
Also called AraC
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
human stem cellsBiological
Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
| Study group | Role | What they receive |
|---|---|---|
| standard arm | Active comparator | standard treatment arm Receives: Drug: Cytarabine |
| OSHO - intensified consolidation | Experimental | Intermediate dose AraC Receives: Drug: Cytarabine |
| OSHO - allografting as consolidation | Experimental | allogeneic stem cell Transplantation versus no transplantation Receives: Biological: human stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
comparison of event free survival (OSHO arm versus Standard intergroup arm)
Measured: after 5 years
Secondary outcomes (2)
OS
Overall survival
Measured: at 5 years
LFS
leukemia free survival
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startApr 2005
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukaemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dietger Niederwieser, Prof., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497002
- Sponsor's protocol ID
- OSHO#069
- Acronym
- AML2004
- Status last verified
- Sep 2022
- First submitted
- 21 Dec 2011
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.
- ClinicalTrials.gov ID
- NCT01497002
- Acronym / sponsor ID
- AML2004 / OSHO#069
- Conditions
- Acute Myeloid Leukaemia
- Keywords
- AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,222 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Apr 2005 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 22 Dec 2011 (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.
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Detailed description
Measuring EFS depending on induction therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard arm | Active comparator | Drug: Cytarabinestandard treatment arm |
| OSHO - intensified consolidation | Experimental | Drug: CytarabineIntermediate dose AraC |
| OSHO - allografting as consolidation | Experimental | Biological: human stem cellsallogeneic stem cell Transplantation versus no transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of both sexes with age > 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
- written informed consent
Key exclusion criteria (18 listed)
- pretreatment of leukemia
- no informed consent
- simultaneous inclusion in other studies
- mental disability
- contraindication for intensive chemotherapy
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 |
|---|---|---|
| CytarabineAlso: AraCInduction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5. | Drug | OSHO - intensified consolidation, standard arm |
| human stem cellsInduction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate | Biological | OSHO - allografting as consolidation |
Primary outcome
Event free survival
Time frame: after 5 years
comparison of event free survival (OSHO arm versus Standard intergroup arm)
2 secondary outcomes
OS
Time frame: at 5 years
LFS
Time frame: at 5 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 31 Jan 2024.
- AML 2004 OSHO #069 (Elderly)Link provided by the sponsor.
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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.
Dietger Niederwieser, Prof. principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytarabine and human stem cells in people with Acute Myeloid Leukaemia, run by University of Leipzig 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 2 inclusion and 18 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 Jan 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Event free survival (time frame: after 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024; AzTrials last refreshed its copy on 3 Nov 2026.