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

Phase 3

• Conditions: Acute Myeloid Leukaemia
• Interventions: Drug: Cytarabine

• Registration Number: NCT01414231
• Lead Sponsor: University of Leipzig

Brief Summary

This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis involves primarily dosing and application of AraC for induction. It is expected that CR rates and as a consequence also LFS are higher in protocols using higher AraC compared to lower doses and that LFS might be superior in the study specific arm compared to the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m\*2 over 20-30-min-iv on day 1 - 3 and AraC 2 x 1 g/m\*2 bid over 3-h-iv on days 1+3+5+7.

A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates evaluated.

It is still unclear if two consolidation therapies are needed before allogeneic or autologous stem cell transplantation. This question is being addressed in the second part of the OSHO study, where patients are randomized to receive either one or two consolidation therapies.

In this study all patients with AML and an age of 18-60 years except M3 are entered

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Status Verified: 2008-04
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11
• Primary Completion: 2013-12
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

Adult patients < or = 60 years acute myelogenous leukemia (AML) AML t(8;21)(q22;q22), AML1 (CBFa)/ETO, AML(inv(16)(p13q22)) und variants (CBFb/MYH11), AML 11q23, MLL-anomalies, AML with normal karyotyp myelodysplastic syndrome (MDS)RAEBT with 20-30% blasts.

de novo AML secundary AML after MDS secundary AML after chemotherapy with alkylantien sekundäre AML after chemotherapy with Epipodophyllotoxin informed consent

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Exclusion Criteria

AML M3 patients included in another clinical trial contraindications for high dose cytotoxic therapy such as renal insufficiency liver insufficiency cardiac insufficiency NYHA III + IV, acute myocardial infarction uncontroled infection like pneumonia with hypoxemia or septic schock pregnancy Karnofski-Index of 10 and less second maligancy severe, decompensated metabolism disorders

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytarabine low dose	Cytarabine	This is the golden standard of AML treatment
Cytarabine intermediate dose	Cytarabine	This is the OSHO internal arm

Primary Outcome Measures

Name	Time	Method
Event free survival	after 5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	at 5 years average
Complete remission	average of 6 weeks
Relapse free survival	at 5 years average

Trial Locations

Locations (1)

University of Leipzig, Hematology; 🇩🇪 Leipzig, Germany