Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a (OSHO#061)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukaemia |
Drug: Cytarabine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Comparison of OSHO Induction vs. the German AML Intergroup Standard, Randomised Comparison of AraC/Mtx vs. Flu/AraC/Mtx in Pts Without CR After One Induction Cycle and Randomized Comparison of One vs. Two Consolidation Therapies. |
- Event free survival [ Time Frame: after 5 years ] [ Designated as safety issue: Yes ]
- Complete remission [ Time Frame: average of 6 weeks ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: at 5 years average ] [ Designated as safety issue: No ]
- Relapse free survival [ Time Frame: at 5 years average ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 850 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cytarabine low dose
This is the golden standard of AML treatment
|
Drug: 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.
|
|
Active Comparator: Cytarabine intermediate dose
This is the OSHO internal arm
|
Drug: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dietger Niederwieser, Prof. | +49 172 3436202 | dietger@medizin.uni-leipzig.de |
| Germany | |
| University of Leipzig, Hematology | Recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Dietger Niederwieser +4934197 ext 13050 dietger@medizin.uni-leipzig.de | |
| Principal Investigator: | Dietger Niederwieser, MD | University of Leipzig Germany |
More Information
No publications provided by University of Leipzig
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. med. Dr. h. c. Dietger Niederwieser, University of Leipzig, Hematology |
| ClinicalTrials.gov Identifier: | NCT01414231 History of Changes |
| Other Study ID Numbers: | AML 2002 #061 |
| Study First Received: | August 5, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Leipzig:
|
AML acute myeloid leukaemia low vs intermediate dose AraC CR rate patients <60 years |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013