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

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

NCT ID: NCT01414231

Condition: Acute Myeloid Leukaemia

Conditions: Official terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine

Conditions: Keywords:
AML
acute myeloid leukaemia
low vs intermediate dose AraC
CR rate
patients <60 years

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cytarabine
Description: 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.
Arm group label: Cytarabine intermediate dose
Arm group label: Cytarabine low dose

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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Leipzig, Hematology

Address:
City: Leipzig
Zip: 04103
Country: Germany

Status: Recruiting

Contact:
Last name: Dietger Niederwieser

Phone: +4934197

Phone ext: 13050
Email: dietger@medizin.uni-leipzig.de

Start date: April 2002

Completion date: July 2014

Lead sponsor:
Agency: University of Leipzig
Agency class: Other

Source: University of Leipzig

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01414231