Clinical trial · Interventional
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.
NCT01497002CI-TRIAL-00073461AML2004completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| human stem cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- standard arm
- description
- standard treatment arm
- interventionNames
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- OSHO - intensified consolidation
- description
- Intermediate dose AraC
- interventionNames
- Drug: Cytarabine
- type
- EXPERIMENTAL
- label
- OSHO - allografting as consolidation
- description
- allogeneic stem cell Transplantation versus no transplantation
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification * written informed consent Exclusion Criteria: * pretreatment of leukemia * no informed consent * simultaneous inclusion in other studies * mental disability * contraindication for intensive chemotherapy * AML FAB M3 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.