Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005863
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy With or Without Filgrastim andor Tretinoin in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol for Patients With High Risk Resistant Refractory Relapsed or Adverse Cytogenetic AML
Status:
COMPLETED
Status Verified Date:
2006-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy It is not yet known whether combination chemotherapy with filgrastim andor tretinoin is more effective than combination chemotherapy alone for acute myeloid leukemia
PURPOSE This randomized phase III trial is studying combination chemotherapy with filgrastim andor tretinoin to see how well they work compared to combination chemotherapy alone in treating patients with acute myeloid leukemia
PURPOSE This randomized phase III trial is studying combination chemotherapy with filgrastim andor tretinoin to see how well they work compared to combination chemotherapy alone in treating patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Compare standard induction chemotherapy with cytarabine daunorubicin and etoposide vs fludarabine and cytarabine in terms of achievement of remission reasons for remission failure duration of remission survival toxicity and supportive care needs in patients with high risk acute myeloid leukemia
Determine if the use of filgrastim G-CSF or tretinoin administered during and following chemotherapy improves outcome in this patient population
Determine the impact of these treatment regimens on quality of life in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to type of disease resistant vs refractory vs relapsed vs adverse cytogenetic age under 15 vs 15 to 29 vs 30 to 49 vs 50-59 vs 60-69 vs 70 and over performance status and de novo and secondary leukemia Patients with relapsed disease are further stratified according to duration of first remission less than 6 months vs 6 to 12 months vs 12 months and over and prior transplantation yes vs no
Patients are randomized into one of two treatment arms for induction chemotherapy
Arm I Patients receive induction chemotherapy consisting of cytarabine IV every 12 hours on days 1-10 daunorubicin IV on days 1 3 and 5 and etoposide IV over 1 hour on days 1-5 Patients receive a second course of therapy with cytarabine IV every 12 hours on days 1-8 and daunorubicin and etoposide as in course 1
Arm II Patients receive 2 courses of induction chemotherapy consisting of fludarabine IV over 30 minutes followed by cytarabine IV over 4 hours on days 1-5
Patients are further randomized into one of two treatment arms for colony stimulating factor therapy
Arm I Patients receive filgrastim G-CSF subcutaneously or IV daily beginning on day 1 of each course of induction chemotherapy and continuing until blood counts recover for up to a maximum of 28 days
Arm II Patients receive no G-CSF during and following induction chemotherapy Patients are further randomized into one of two treatment arms for retinoid therapy
Arm I Patients receive oral tretinoin daily beginning on day 1 of induction chemotherapy and continuing for up to a maximum of 90 days
Arm II Patients receive no retinoid therapy during and following induction chemotherapy
Following completion of induction chemotherapy patients achieving complete remission and blood count recovery may receive subsequent therapy consisting of consolidation chemotherapy andor autologous or allogeneic transplantation
Quality of life is assessed at 3 months
PROJECTED ACCRUAL Approximately 800-1000 patients will be accrued for this study within 4-5 years
Compare standard induction chemotherapy with cytarabine daunorubicin and etoposide vs fludarabine and cytarabine in terms of achievement of remission reasons for remission failure duration of remission survival toxicity and supportive care needs in patients with high risk acute myeloid leukemia
Determine if the use of filgrastim G-CSF or tretinoin administered during and following chemotherapy improves outcome in this patient population
Determine the impact of these treatment regimens on quality of life in these patients
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to type of disease resistant vs refractory vs relapsed vs adverse cytogenetic age under 15 vs 15 to 29 vs 30 to 49 vs 50-59 vs 60-69 vs 70 and over performance status and de novo and secondary leukemia Patients with relapsed disease are further stratified according to duration of first remission less than 6 months vs 6 to 12 months vs 12 months and over and prior transplantation yes vs no
Patients are randomized into one of two treatment arms for induction chemotherapy
Arm I Patients receive induction chemotherapy consisting of cytarabine IV every 12 hours on days 1-10 daunorubicin IV on days 1 3 and 5 and etoposide IV over 1 hour on days 1-5 Patients receive a second course of therapy with cytarabine IV every 12 hours on days 1-8 and daunorubicin and etoposide as in course 1
Arm II Patients receive 2 courses of induction chemotherapy consisting of fludarabine IV over 30 minutes followed by cytarabine IV over 4 hours on days 1-5
Patients are further randomized into one of two treatment arms for colony stimulating factor therapy
Arm I Patients receive filgrastim G-CSF subcutaneously or IV daily beginning on day 1 of each course of induction chemotherapy and continuing until blood counts recover for up to a maximum of 28 days
Arm II Patients receive no G-CSF during and following induction chemotherapy Patients are further randomized into one of two treatment arms for retinoid therapy
Arm I Patients receive oral tretinoin daily beginning on day 1 of induction chemotherapy and continuing for up to a maximum of 90 days
Arm II Patients receive no retinoid therapy during and following induction chemotherapy
Following completion of induction chemotherapy patients achieving complete remission and blood count recovery may receive subsequent therapy consisting of consolidation chemotherapy andor autologous or allogeneic transplantation
Quality of life is assessed at 3 months
PROJECTED ACCRUAL Approximately 800-1000 patients will be accrued for this study within 4-5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20008 | None | None | None |
| MRC-LEUK-AML-HR | None | None | None |