Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146120
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2005-09-01
Brief Title:
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults 18-60 Years According to the Cytogenetic Result
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
Official Title:
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults 18-60 Years According to the Cytogenetic Result
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The concept of the investigators risk-adapted multicenter treatment trial for younger adults AML HD98A is based on the results of the AML HD93 trial and on published data Definition of risk groups is different compared to the AML HD93 trial high-risk refractory disease after first induction therapy andor high risk karyotype abn3q -55q- -77q- abn12p abn17p complex intermediate-risk complete remission after induction therapy and intermediate risk karyotype normal abn11q23 abn16q22 other rare aberrations low-risk complete remission after induction therapy and low risk karyotype t821 Patients exhibiting a t1517 were treated in a separated trial APL HD95 Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM all-trans retinoic acid high-dose cytarabine and mitoxantrone and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation Second consolidation therapy was stratified according to the risk definition For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM The other intermediate-risk patients are assigned to autologous transplantation For low-risk patients a second course of HAM is assigned
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None