Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003934
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
1999-11-01
Brief Title:
Tretinoin Cytarabine and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide AS2O3 NSC 706363 as Initial Consolidation Therapy Followed by Maintenance Therapy With Intermittent Tretinoin Versus Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients With Untreated Acute Promyelocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-06
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 randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin combination chemotherapy and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously Drugs used in chemotherapy such as daunorubicin cytarabine mercaptopurine methotrexate and arsenic trioxide work in different ways to stop cancer cells from dividing so they stop growing or die Tretinoin may help leukemia cells develop into normal white blood cells It is not yet known which regimen is more effective for acute promyelocytic leukemia
Detailed Description:
PRIMARY OBJECTIVES
i To compare the efficacy event-free survival and toxicities of two inductionconsolidation therapies for patients with untreated APL ATRAara-Cdaunorubicin with or without arsenic trioxide As2O3
II To evaluate the efficacy disease-free survival and toxicities of maintenance therapy with intermittent ATRA vs intermittent ATRA plus 6-MPMTX for patients with APL who achieve a complete response
III To explore the relationship between CD56 expression at diagnosis and clinical outcomes
IV To evaluate the cardiac toxicity of intensive daunorubicin therapy as given in this study to pediatric patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 15 vs 15 to 60 vs over 60 for the induction phase Patients are stratified according to age as in the induction phase and the consolidation arm with vs without arsenic trioxide for the consolidation phase Patients under age 5 do not receive arsenic trioxide
Induction All patients receive oral tretinoin every 12 hours beginning on day 1 until complete response or for a maximum of 90 days Patients also receive daunorubicin IV on days 3-6 and cytarabine IV continuously on days 3-9
Consolidation All patients achieving complete response CR or partial response PR after completion of tretinoin proceed to consolidation within 2 weeks of achieving CR or PR but not prior to 30 days from the start of induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tretinoin every 12 hours on days 1-7 and daunorubicin IV on days 1-2 or days 1-3 depending on age Patients may receive an additional course Treatment begins no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery
Arm II Patients receive arsenic trioxide IV over 2 hours daily 5 days a week for 5 weeks After a 2-week rest patients receive a second course of arsenic trioxide Patients then receive tretinoin and daunorubicin as in arm I
Maintenance Patients maintaining CR or PR after consolidation therapy proceed to maintenance therapy beginning no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tretinoin every 12 hours for 7 days every other week for 1 year
Arm II Patients receive oral tretinoin as in arm I above Patients also receive oral mercaptopurine once a day and oral methotrexate once weekly for up to 1 year
Maintenance therapy continues for up to 1 year in the absence of unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 522 patients 456 adults and 66 pediatric will be accrued for this study within 475 years
i To compare the efficacy event-free survival and toxicities of two inductionconsolidation therapies for patients with untreated APL ATRAara-Cdaunorubicin with or without arsenic trioxide As2O3
II To evaluate the efficacy disease-free survival and toxicities of maintenance therapy with intermittent ATRA vs intermittent ATRA plus 6-MPMTX for patients with APL who achieve a complete response
III To explore the relationship between CD56 expression at diagnosis and clinical outcomes
IV To evaluate the cardiac toxicity of intensive daunorubicin therapy as given in this study to pediatric patients
OUTLINE This is a randomized multicenter study Patients are stratified according to age under 15 vs 15 to 60 vs over 60 for the induction phase Patients are stratified according to age as in the induction phase and the consolidation arm with vs without arsenic trioxide for the consolidation phase Patients under age 5 do not receive arsenic trioxide
Induction All patients receive oral tretinoin every 12 hours beginning on day 1 until complete response or for a maximum of 90 days Patients also receive daunorubicin IV on days 3-6 and cytarabine IV continuously on days 3-9
Consolidation All patients achieving complete response CR or partial response PR after completion of tretinoin proceed to consolidation within 2 weeks of achieving CR or PR but not prior to 30 days from the start of induction Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tretinoin every 12 hours on days 1-7 and daunorubicin IV on days 1-2 or days 1-3 depending on age Patients may receive an additional course Treatment begins no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery
Arm II Patients receive arsenic trioxide IV over 2 hours daily 5 days a week for 5 weeks After a 2-week rest patients receive a second course of arsenic trioxide Patients then receive tretinoin and daunorubicin as in arm I
Maintenance Patients maintaining CR or PR after consolidation therapy proceed to maintenance therapy beginning no earlier than 2 weeks and no later than 4 weeks after hematopoietic recovery Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral tretinoin every 12 hours for 7 days every other week for 1 year
Arm II Patients receive oral tretinoin as in arm I above Patients also receive oral mercaptopurine once a day and oral methotrexate once weekly for up to 1 year
Maintenance therapy continues for up to 1 year in the absence of unacceptable toxicity
Patients are followed every 2 months for 2 years every 3 months for 1 year every 6 months for 2 years and then annually for 5 years
PROJECTED ACCRUAL A total of 522 patients 456 adults and 66 pediatric will be accrued for this study within 475 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| C9710 | None | None | None |
| CDR0000067126 | None | None | None |
| CALGB-C9710 | None | None | None |