Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186966
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2005-09-12
Brief Title:
Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
Sponsor:
Dutch Childhood Oncology Group
Organization:
Dutch Childhood Oncology Group
Study Overview
Official Title:
A Randomized Phase III Study of the Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2011-04
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:
None
Brief Summary:
This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia AML such a disease The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine ara-C and G-CSFFLAG in children with relapsed and refractory AML
Detailed Description:
Secondary objectives of this trial are
To determine the toxicity of liposomal daunorubicin when added to FLAG in terms of mucosal toxicity bone marrow aplasia short- and long-term cardiotoxicity and other side effects as compared to patients treated with FLAG only
To determine the long-term clinical outcome prospectively in a large group of children with refractory and relapsed acute myeloid leukemia
To determine the changes in minimal residual disease over time and the prognostic significance of minimal residual disease determined at various time-points
To determine the relation between in vitro cellular drug resistance and clinical and cell biological features minimal residual disease and clinical outcome in this patient group
To determine the pharmacokinetics of liposomal daunorubicin in relation to its toxicity and efficacy
Reinduction treatment will be done with 2 courses of combination chemotherapy with FLAG fludarabine ara-C and G-CSF in both courses as standard treatment In the first course there will be a randomisation for liposomal daunorubicin DaunoXome to be added or not The second course should always concern FLAG If patients have 20 of blasts in the bone marrow after the 1st course or if they are not in complete remission CR after the 2nd course they will go off protocol Patients in CR after reinduction treatment can immediately proceed to stem cell transplantation Consolidation chemotherapy should be given if SCT is delayed A 3rd course of intensive chemotherapy VP16 and continuous infusion with cytarabine is the general recommendation In selected patients a low intensity consolidation may be preferred and such a schedule is described as well The type of SCT is based on the risk-group Preferably a matched sibling donor MSD SCT is performed If a MSD is not available all patients are candidates for a matched unrelated donor MUD SCT If a MUD is also not available patients with primary refractory disease early relapse within 1 year from diagnosis or greater than or equal to 2nd relapse are candidates for the more experimental haplo-identical donor HID SCT in view of the dismal prognosis However patients with a late relapse 1 year from initial diagnosis have a better prognosis and should be offered an autologous SCT if a MSD or MUD SCT is not possible Only in case of autologous SCT maintenance treatment andor adjuvant immunotherapy could be considered
To determine the toxicity of liposomal daunorubicin when added to FLAG in terms of mucosal toxicity bone marrow aplasia short- and long-term cardiotoxicity and other side effects as compared to patients treated with FLAG only
To determine the long-term clinical outcome prospectively in a large group of children with refractory and relapsed acute myeloid leukemia
To determine the changes in minimal residual disease over time and the prognostic significance of minimal residual disease determined at various time-points
To determine the relation between in vitro cellular drug resistance and clinical and cell biological features minimal residual disease and clinical outcome in this patient group
To determine the pharmacokinetics of liposomal daunorubicin in relation to its toxicity and efficacy
Reinduction treatment will be done with 2 courses of combination chemotherapy with FLAG fludarabine ara-C and G-CSF in both courses as standard treatment In the first course there will be a randomisation for liposomal daunorubicin DaunoXome to be added or not The second course should always concern FLAG If patients have 20 of blasts in the bone marrow after the 1st course or if they are not in complete remission CR after the 2nd course they will go off protocol Patients in CR after reinduction treatment can immediately proceed to stem cell transplantation Consolidation chemotherapy should be given if SCT is delayed A 3rd course of intensive chemotherapy VP16 and continuous infusion with cytarabine is the general recommendation In selected patients a low intensity consolidation may be preferred and such a schedule is described as well The type of SCT is based on the risk-group Preferably a matched sibling donor MSD SCT is performed If a MSD is not available all patients are candidates for a matched unrelated donor MUD SCT If a MUD is also not available patients with primary refractory disease early relapse within 1 year from diagnosis or greater than or equal to 2nd relapse are candidates for the more experimental haplo-identical donor HID SCT in view of the dismal prognosis However patients with a late relapse 1 year from initial diagnosis have a better prognosis and should be offered an autologous SCT if a MSD or MUD SCT is not possible Only in case of autologous SCT maintenance treatment andor adjuvant immunotherapy could be considered
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TRIAL Relapsed AML 200101 | None | None | None |