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

NCT ID: NCT01414231

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2014-07-31

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

Conditions

Acute Myeloid Leukaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytarabine low dose

This is the golden standard of AML treatment

Group Type: ACTIVE_COMPARATOR

Cytarabine

Intervention Type: DRUG

Intermediate dose against low dose; IDA 12 mg/m2 iv days 1 - 3 and AraC 2 x 1 g/m2 bid on days 1+3+5+7 vs. AraC 100 mg/m2/day i.v.-for 7 days and Daunorubicin 60 mg/m2/Tag on days 3, 4 und 5.

Cytarabine intermediate dose

This is the OSHO internal arm

Group Type: ACTIVE_COMPARATOR

Cytarabine

Intervention Type: DRUG

Intermediate dose against low dose; IDA 12 mg/m2 iv days 1 - 3 and AraC 2 x 1 g/m2 bid on days 1+3+5+7 vs. AraC 100 mg/m2/day i.v.-for 7 days and Daunorubicin 60 mg/m2/Tag on days 3, 4 und 5.

Interventions

Cytarabine

Intermediate dose against low dose; IDA 12 mg/m2 iv days 1 - 3 and AraC 2 x 1 g/m2 bid on days 1+3+5+7 vs. AraC 100 mg/m2/day i.v.-for 7 days and Daunorubicin 60 mg/m2/Tag on days 3, 4 und 5.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

University of Leipzig, Hematology

Principal Investigators

Dietger Niederwieser, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

University of Leipzig, Hematology

Leipzig, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dietger Niederwieser, Prof.

Role: CONTACT

dietger@medizin.uni-leipzig.de

+49 172 3436202

Facility Contacts

Dietger Niederwieser

Role: primary

dietger@medizin.uni-leipzig.de

+4934197 ext. 13050

References

Buchner T, Schlenk RF, Schaich M, Dohner K, Krahl R, Krauter J, Heil G, Krug U, Sauerland MC, Heinecke A, Spath D, Kramer M, Scholl S, Berdel WE, Hiddemann W, Hoelzer D, Hehlmann R, Hasford J, Hoffmann VS, Dohner H, Ehninger G, Ganser A, Niederwieser DW, Pfirrmann M. Acute Myeloid Leukemia (AML): different treatment strategies versus a common standard arm--combined prospective analysis by the German AML Intergroup. J Clin Oncol. 2012 Oct 10;30(29):3604-10. doi: 10.1200/JCO.2012.42.2907. Epub 2012 Sep 10.

Reference Type: DERIVED

PMID: 22965967 (View on PubMed)

Other Identifiers

AML 2002 #061

Identifier Type: -

Identifier Source: org_study_id