Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00853008
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2009-02-25
Brief Title:
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2020-04
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:
LAL-AR2003
Brief Summary:
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors age WBC count immunophenotype cytogenetics and speed in response to therapy for treatment decisions On the other hand the systematic use of allogeneic SCT for all adult patients pts with Ph- HR-ALL is still a matter of debate The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy chemotherapy or allogeneic SCT according to early bone marrow blast clearance and MRD levels assessed by cytofluorometry at the end of induction and consolidation therapy in HR Ph- adult ALL patients
Detailed Description:
HR ALL included one or more of the following baseline parameters age 30-60 yr WBC count 25x109L and 11q23 or MLL rearrangements Induction therapy included vincristine prednisone and daunorubicin for 4 weeks In pts with slow cytologic response to therapy 10 blasts in bone marrow assessed on d14 intensified induction with high dose ARA-C and mitoxantrone was administered Early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate high-dose ARA-C and high-dose asparaginase Pts with slow cytologic response on d14 or MRD level 005 after consolidation were assigned to allogeneic SCT related or unrelated and those with standard cytologic response on d14 and MRD level 005 after consolidation received 3 additional cycles of delayed consolidation identical to those of early consolidation followed by maintenance therapy up to 2yr in CR
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