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NCT Number: NCT01497002

Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

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Key information

Conditions

Acute Myeloid Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Leipzig, Hematology

Leipzig, 04103, Germany

About this study

Measuring EFS depending on induction therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine

Drug

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.

Other names: AraC

human stem cells

Biological

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

Primary outcomes

  1. Event free survival

    Time frame: after 5 years

    comparison of event free survival (OSHO arm versus Standard intergroup arm)

Secondary outcomes

  1. OS

    Time frame: at 5 years

    Overall survival

  2. LFS

    Time frame: at 5 years

    leukemia free survival

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.

Acronym: AML2004

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2011
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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