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Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

NCT01497002•University of Leipzig

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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 %
+8 more criteria

Locations (1)

University of Leipzig, Hematology

Leipzig, Germany

Key Dates

Start Date

April 1, 2005

Primary Completion Date

July 18, 2018

Completion Date

July 18, 2018

Last Updated

January 31, 2024

Enrollment

1,222

ACTUAL participants

Conditions

Acute Myeloid Leukaemia

Interventions

Cytarabine

DRUG

human stem cells

BIOLOGICAL

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

NCT07148180

Acute Myeloid Leukaemia (AML)Leukemia+2 more

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RECRUITINGPHASE1

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

NCT05534620

Acute Myeloid Leukaemia (AML)Myelodysplastic Syndrome (MDS)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

GITMO AML/MDS-Relapse Registry Study

A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT