Comparison of the OSHO Protocol to a Standard Arm Protoco... | NCT01497002

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

NCT01497002

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Jan 31, 2024Actual

Enrollment

1,222Actual

Phase

Phase 3

Conditions

Acute Myeloid Leukaemia

Interventions

Cytarabine
human stem cells

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005Actual

Primary Completion Date

Jul 18, 2018Actual

Completion Date

Jul 18, 2018Actual

First Submitted Date

Dec 21, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Measuring EFS depending on induction therapy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event free survival	comparison of event free survival (OSHO arm versus Standard intergroup arm)	after 5 years

Secondary Outcomes

Measure	Description	Time Frame
OS	Overall survival	at 5 years
LFS	leukemia free survival	at 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dietger Niederwieser, Prof.	University of Leipzig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig, Hematology		Leipzig		04103	Germany

Label	URL
AML 2004 OSHO #069 (Elderly)	View source

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Sep 15, 2022	Jan 19, 2024	SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003561	Cytarabine
C098672	TNK1 protein, human

Ancestor Terms

ID	Term
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided