At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,500 enrolled
Drug / intervention
Cytarabine +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risk-stratified Therapy for Primary and Secondary AML and MDS. A Randomized Study by AMLCG in Relation to Cytogenetically Defined Prognostic Factors (1) on the Role of High-dose AraC as Part of Double Induction, (2) on G-CSF Priming, and (3) on High-dose Chemotherapy With Stem Cell Transplantation
In Brief
A Phase 3 clinical trial evaluating Cytarabine, Thioguanine, and 5 other interventions for Acute Myeloid Leukemia. Completed, enrolled 3,500 participants across 1 site.
Detailed Summary
The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesGermany
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 1999
First PostedDec 2005
Primary CompletionJan 2007
Study CompletionOct 2012
TodayJul 2026
First PostedDec 15, 2005
Enrollment StartJun 1, 1999
Primary CompletionJan 1, 2007
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 20.5 years ago
Interventions
Cytarabinedrug
see protocol
Thioguaninedrug
see protocol
Daunorubicindrug
see protocol
Cyclophosphamidedrug
see protocol
G-CSFdrug
see protocol
Autologous stem cell transplantationprocedure
for details see protocol
Allogeneic stem cell transplantationprocedure
for details see protocol