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

NCT01497002 | Completed Phase 3 DMC

• 1 other identifier: OSHO#069
• Study Type: interventional
• Target: 1,222
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukaemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Event free survival

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

  after 5 years

Secondary Outcomes (2)

• OS

  at 5 years

• LFS

  at 5 years

Study Arms (3)

standard arm

ACTIVE COMPARATOR

standard treatment arm

Drug: Cytarabine

OSHO - intensified consolidation

EXPERIMENTAL

Intermediate dose AraC

Drug: Cytarabine

OSHO - allografting as consolidation

EXPERIMENTAL

allogeneic stem cell Transplantation versus no transplantation

Biological: human stem cells

Interventions

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.

Also known as: AraC

OSHO - intensified consolidation; standard arm

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

OSHO - allografting as consolidation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification
• written informed consent

You may not qualify if:

• pretreatment of leukemia
• no informed consent
• 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

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University of Leipzig, Hematology

Leipzig, 04103, Germany

Location

Related Links

• AML 2004 OSHO #069 (Elderly)

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; TNK1 protein, human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dietger Niederwieser, Prof.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 22, 2011
• Study Start: April 1, 2005
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: January 31, 2024

Record last verified: 2022-09

Locations

DE (1)