Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358072
Status:
COMPLETED
Last Update Posted:
2010-12-29
First Post:
2006-07-26
Brief Title:
Treatment of Adult ALL With an MRD-directed Programme
Sponsor:
Northern Italy Leukemia Group
Organization:
Northern Italy Leukemia Group
Study Overview
Official Title:
Treatment of Adult Acute Lymphoblastic Leukemia Using a Post-remission Programme Whose Intensity Varies Depending on the Risk Class Defined on the Basis of Minimal Residual Disease
Status:
COMPLETED
Status Verified Date:
2010-12
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 study aims to optimize the concept of risk-oriented postremission consolidation therapy by offering i standard consolidation-maintenance to patients at lowest risk of relapse as defined by MRDMinimal Residual Disease negative status and ii allogeneic stem cell transplantation relatedunrelated donor available or multicycle high-dose therapy with autologous blood stem cell transplant no donor to patients at highest risk of relapse as defined by MRD status
The prognostic role of MRD evaluation in unselected patients will be evaluated
The prognostic role of MRD evaluation in unselected patients will be evaluated
Detailed Description:
Improved outcome of adult ALL through the application of
Risk-adapted induction cycle no 1 IVAP ie idarubicin-vincristine-asparaginase-prednisone plus fractionated cyclophosphamide in T-ALLand imatinib in PhBCR-ABL ALL
Risk stratification clinical according to morphology immunophenotype cytogentics and molecular biology results Standard risk SR is defined by pre-B CD10 phenotype PhBCR-ABL- status and a blast count 10x10e9L All other subgroups are HR high-risk except for PhBCR-ABL and t411 ALL VHR very high-risk
Homogeneous early consolidation programme including both conventional therapy with idarubicin-vincristine-cyclophosphamide-dexamethasoneprednisonecycles no 23568 and high-dose treatemt with MTXAra-C cycles no 47 and meningeal prophylaxis triple intrathecal therapy x8-12 skull irradiation plus imatinib in Ph ALL Phase A Autologous bllo stem cells are mobilized and cryopreserved after cycle no 4
Serial evaluation of minimal residual disease MRD with RQ-PCT technology aiming to define in individual patients the rate of reduction during early consolidation The molecular study was centralized and aimed at obtaining one or more patient-specific probeswith a sensitivity of at least 10e-3 Patient bone marrow was sampled for MRD analysis at timepoints 13 ie after cycles no35 and 7 Only patients with a negative result at timepoint 3 and a negativelow positive 10e-4 result at timepoint 3 are considered MRD- all other combinations being regarded MRD
Phase B therapy according to MRD results and ALL subset
MRD- nonPht411 standard maintenance
MRD nonPht411 allogeneic stem cell transplantation from siblingMUD or alternatively intensified high-dose therapy 2-4 hypercycleswith autologous stem cell support and anti CD20 MoAb if CD20 followed by maintenance Each hypercycle consists of high-dose mercaptopurine-etoposide-melphalan cycles no 13 or methotrexate-cytarabine cycles no 24
MRD unknown nonPht411 treatment by clinical risk SR maintenance HR as per MRD
Pht411 allogeneic stem cell transplantation as soon as possible into complete remission if a transplant is not possible consolidation is as for HR patients each cycle is supplemented by imatinib in Ph ALL
The illustrated strategy aims to optimize postremission consolidation therapy by offering standard treatment only to patients at lowest risk of relapse MRD- thereby reducing the risks of high dose treatments expected TRM from allogeneic SCT 20-30 while maintaining the latter approach in MRD cases and very HR subsets
The prognostic role of MRD evaluation in unselected patients will be evaluated
Risk-adapted induction cycle no 1 IVAP ie idarubicin-vincristine-asparaginase-prednisone plus fractionated cyclophosphamide in T-ALLand imatinib in PhBCR-ABL ALL
Risk stratification clinical according to morphology immunophenotype cytogentics and molecular biology results Standard risk SR is defined by pre-B CD10 phenotype PhBCR-ABL- status and a blast count 10x10e9L All other subgroups are HR high-risk except for PhBCR-ABL and t411 ALL VHR very high-risk
Homogeneous early consolidation programme including both conventional therapy with idarubicin-vincristine-cyclophosphamide-dexamethasoneprednisonecycles no 23568 and high-dose treatemt with MTXAra-C cycles no 47 and meningeal prophylaxis triple intrathecal therapy x8-12 skull irradiation plus imatinib in Ph ALL Phase A Autologous bllo stem cells are mobilized and cryopreserved after cycle no 4
Serial evaluation of minimal residual disease MRD with RQ-PCT technology aiming to define in individual patients the rate of reduction during early consolidation The molecular study was centralized and aimed at obtaining one or more patient-specific probeswith a sensitivity of at least 10e-3 Patient bone marrow was sampled for MRD analysis at timepoints 13 ie after cycles no35 and 7 Only patients with a negative result at timepoint 3 and a negativelow positive 10e-4 result at timepoint 3 are considered MRD- all other combinations being regarded MRD
Phase B therapy according to MRD results and ALL subset
MRD- nonPht411 standard maintenance
MRD nonPht411 allogeneic stem cell transplantation from siblingMUD or alternatively intensified high-dose therapy 2-4 hypercycleswith autologous stem cell support and anti CD20 MoAb if CD20 followed by maintenance Each hypercycle consists of high-dose mercaptopurine-etoposide-melphalan cycles no 13 or methotrexate-cytarabine cycles no 24
MRD unknown nonPht411 treatment by clinical risk SR maintenance HR as per MRD
Pht411 allogeneic stem cell transplantation as soon as possible into complete remission if a transplant is not possible consolidation is as for HR patients each cycle is supplemented by imatinib in Ph ALL
The illustrated strategy aims to optimize postremission consolidation therapy by offering standard treatment only to patients at lowest risk of relapse MRD- thereby reducing the risks of high dose treatments expected TRM from allogeneic SCT 20-30 while maintaining the latter approach in MRD cases and very HR subsets
The prognostic role of MRD evaluation in unselected patients will be evaluated
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