Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085709
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2004-06-14
Brief Title:
S0106 Cytarabine and Daunorubicin w or wo Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Study of the Addition of Gemtuzumab Ozogamicin Mylotarg During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin Mylotarg or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2015-09
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 such as cytarabine and daunorubicin work in different ways to stop cancer cells from dividing so they stop growing and die Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo first occurrence acute myeloid leukemia
PURPOSE This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia
PURPOSE This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia
Detailed Description:
OBJECTIVES
Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy
Compare the complete remission rate in patients treated with these regimens
Compare the frequency and severity of the toxic effects of these regimens in these patients
Other objectives if funding allows
Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin
Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens
Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens
Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified during induction therapy according to age 35 years vs 35 years and during post-consolidation therapy according to preinduction cytogenetic risk group
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive daunorubicin IV on days 1-3 cytarabine IV continuously on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 4 Patients receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover
Arm II Patients receive daunorubicin cytarabine and G-CSF or GM-CSF as in arm I
Patients in both arms undergo bone marrow aspiration and biopsy on day 14 and on day 19 if applicable and then proceed to reinduction therapy
Reinduction therapy Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7 Patients also receive G-CSF or GM-CSF as in induction therapy
Patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status proceed to consolidation therapy
Consolidation therapy Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1 3 and 5 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients who maintain A1 bone marrow B1 peripheral blood and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy
Post-consolidation therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no additional therapy Patients are observed at days 30 and 60 after randomization
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 684 patients 342 per treatment arm will be accrued for this study within 45-5 years
Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy
Compare the complete remission rate in patients treated with these regimens
Compare the frequency and severity of the toxic effects of these regimens in these patients
Other objectives if funding allows
Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin
Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens
Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens
Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified during induction therapy according to age 35 years vs 35 years and during post-consolidation therapy according to preinduction cytogenetic risk group
Induction therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive daunorubicin IV on days 1-3 cytarabine IV continuously on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 4 Patients receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover
Arm II Patients receive daunorubicin cytarabine and G-CSF or GM-CSF as in arm I
Patients in both arms undergo bone marrow aspiration and biopsy on day 14 and on day 19 if applicable and then proceed to reinduction therapy
Reinduction therapy Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7 Patients also receive G-CSF or GM-CSF as in induction therapy
Patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status proceed to consolidation therapy
Consolidation therapy Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1 3 and 5 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Patients who maintain A1 bone marrow B1 peripheral blood and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy
Post-consolidation therapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no additional therapy Patients are observed at days 30 and 60 after randomization
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 684 patients 342 per treatment arm will be accrued for this study within 45-5 years
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 |
|---|---|---|---|
| S0106 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |