Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005823
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2000-06-02
Brief Title:
Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Leukemia Research Fund
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Trial for Patients With Acute Myeloid Leukemia or High Risk Myelodysplatic Syndrome Aged 60 or Over
Status:
COMPLETED
Status Verified Date:
2006-09
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 use different ways to stop cancer cells from dividing so they stop growing or die It is not yet known if stronger doses of chemotherapy given over a longer period of time are as well tolerated or as effective as less intensive chemotherapy
PURPOSE This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome
PURPOSE This randomized phase III trial is studying intensive regimens of chemotherapy to see how well they work compared to nonintensive regimens of chemotherapy in treating older patients with acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Compare the response rate survival quality of life and supportive care requirements with intensive versus nonintensive chemotherapy in older patients with acute myeloid leukemia or high risk myelodysplastic syndrome
Compare response achievement response duration survival toxicity and supportive care requirements with differing doses of daunorubicin and cytarabine in these patients receiving intensive chemotherapy
Determine the efficacy of PSC 833 in enhancing the effects of daunorubicin in these patients receiving intensive chemotherapy
Compare relapse rate deaths in complete remission disease free survival and survival with short versus long intensive chemotherapy in these patients
Compare response achievement response duration survival toxicity quality of life and resource use with hydroxyurea versus cytarabine in these patients receiving low dose chemotherapy
Determine response achievement response duration survival toxicity quality of life and supportive care requirements with the addition of tretinoin to the nonintensive chemotherapy in these patients
Assess the correlation between P-gp and BCL-2 in family members and treatment outcomes and other prognostic factors in these patients with these treatment regimens
OUTLINE This is a randomized multicenter study Patients are randomized or electively assigned to either intensive or nonintensive chemotherapy
Intensive chemotherapy
Induction therapy Patients are randomized to 1 of 6 treatment arms Patients receive 2 courses of chemotherapy comprising 1 of 2 daunorubicin doses 1 of 2 cytarabine doses thioguanine and with or without PSC 833
Patients receive daunorubicin IV once daily on days 1-3 with cytarabine IV twice daily and oral thioguanine once daily on days 1-10 during course 1 Treatment repeats in approximately 31 days as in course 1 except cytarabine and thioguanine are given only on days 1-8
Arm I Patients receive higher dose of daunorubicin lower dose of cytarabine and thioguanine
Arm II Patients receive higher dose of daunorubicin higher dose of cytarabine and thioguanine
Arm III Patients receive lower dose of daunorubicin lower dose of cytarabine and thioguanine
Arm IV Patients receive lower dose of daunorubicin higher dose of cytarabine and thioguanine
Arm V Patients receive treatment as in arm III in combination with continuous infusion of PSC 833 beginning day 1
Arm VI Patients receive treatment as in arm IV in combination with continuous infusion of PSC 833 beginning on day 1
Patients with refractory disease after the first course of induction chemotherapy may continue with the intensive protocol arm or enter the nonintensive arm Patients who do not achieve complete remission after completion of induction chemotherapy are removed from study Patients in complete remission after induction therapy receive consolidation therapy
Consolidation therapy Patients in complete remission after induction are randomized to either short or long consolidation
Short consolidation Patients receive mitoxantrone IV on days 1-3 and cytarabine IV over 2 hours twice daily on days 1-3
Long consolidation Patients complete short consolidation and then receive idarubicin IV over 5 minutes once daily on days 1 and 3 cytarabine IV over 2 hours twice daily and etoposide IV over 1 hour once daily on days 1-3
Non-intensive chemotherapy
Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral hydroxyurea as necessary to control WBC count until treatment failure
Arm II Patients receive hydroxyurea as in arm I and oral tretinoin daily for up to 16 weeks
Arm III Patients receive low dose cytarabine subcutaneously twice daily on days 1-10 every 28 days for a minimum of 4 courses
Arm IV Patients receive cytarabine as in arm III plus oral tretinoin daily for up to 16 weeks
NOTE Patients with liver function test 2 times upper limit of normal are not eligible for nonintensive randomization
Quality of life is assessed at study entry and then at 1 3 and 6 months
Patients are followed at one year
PROJECTED ACCRUAL Approximately 2000 patients 1200 to intensive arm and 800 to nonintensive arm will be accrued for this study over 5 years
Compare the response rate survival quality of life and supportive care requirements with intensive versus nonintensive chemotherapy in older patients with acute myeloid leukemia or high risk myelodysplastic syndrome
Compare response achievement response duration survival toxicity and supportive care requirements with differing doses of daunorubicin and cytarabine in these patients receiving intensive chemotherapy
Determine the efficacy of PSC 833 in enhancing the effects of daunorubicin in these patients receiving intensive chemotherapy
Compare relapse rate deaths in complete remission disease free survival and survival with short versus long intensive chemotherapy in these patients
Compare response achievement response duration survival toxicity quality of life and resource use with hydroxyurea versus cytarabine in these patients receiving low dose chemotherapy
Determine response achievement response duration survival toxicity quality of life and supportive care requirements with the addition of tretinoin to the nonintensive chemotherapy in these patients
Assess the correlation between P-gp and BCL-2 in family members and treatment outcomes and other prognostic factors in these patients with these treatment regimens
OUTLINE This is a randomized multicenter study Patients are randomized or electively assigned to either intensive or nonintensive chemotherapy
Intensive chemotherapy
Induction therapy Patients are randomized to 1 of 6 treatment arms Patients receive 2 courses of chemotherapy comprising 1 of 2 daunorubicin doses 1 of 2 cytarabine doses thioguanine and with or without PSC 833
Patients receive daunorubicin IV once daily on days 1-3 with cytarabine IV twice daily and oral thioguanine once daily on days 1-10 during course 1 Treatment repeats in approximately 31 days as in course 1 except cytarabine and thioguanine are given only on days 1-8
Arm I Patients receive higher dose of daunorubicin lower dose of cytarabine and thioguanine
Arm II Patients receive higher dose of daunorubicin higher dose of cytarabine and thioguanine
Arm III Patients receive lower dose of daunorubicin lower dose of cytarabine and thioguanine
Arm IV Patients receive lower dose of daunorubicin higher dose of cytarabine and thioguanine
Arm V Patients receive treatment as in arm III in combination with continuous infusion of PSC 833 beginning day 1
Arm VI Patients receive treatment as in arm IV in combination with continuous infusion of PSC 833 beginning on day 1
Patients with refractory disease after the first course of induction chemotherapy may continue with the intensive protocol arm or enter the nonintensive arm Patients who do not achieve complete remission after completion of induction chemotherapy are removed from study Patients in complete remission after induction therapy receive consolidation therapy
Consolidation therapy Patients in complete remission after induction are randomized to either short or long consolidation
Short consolidation Patients receive mitoxantrone IV on days 1-3 and cytarabine IV over 2 hours twice daily on days 1-3
Long consolidation Patients complete short consolidation and then receive idarubicin IV over 5 minutes once daily on days 1 and 3 cytarabine IV over 2 hours twice daily and etoposide IV over 1 hour once daily on days 1-3
Non-intensive chemotherapy
Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral hydroxyurea as necessary to control WBC count until treatment failure
Arm II Patients receive hydroxyurea as in arm I and oral tretinoin daily for up to 16 weeks
Arm III Patients receive low dose cytarabine subcutaneously twice daily on days 1-10 every 28 days for a minimum of 4 courses
Arm IV Patients receive cytarabine as in arm III plus oral tretinoin daily for up to 16 weeks
NOTE Patients with liver function test 2 times upper limit of normal are not eligible for nonintensive randomization
Quality of life is assessed at study entry and then at 1 3 and 6 months
Patients are followed at one year
PROJECTED ACCRUAL Approximately 2000 patients 1200 to intensive arm and 800 to nonintensive arm will be accrued for this study over 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 |
|---|---|---|---|
| ISRCTN62207270 | None | None | None |
| LRF-AML14 | None | None | None |
| EU-20016 | None | None | None |