Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004215
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-01-28
Brief Title:
Leridistim Compared With Filgrastim in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Clinical Protocol for a Phase II Study of Leridistim SC-70935 in Adult Patients Age55 With Acute Myeloid Leukemia AML Receiving Chemotherapy With the Cytarabine and Daunorubicin 73 Regimen
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:
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 leridistim and filgrastim 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
PURPOSE Randomized phase II trial to compare the effectiveness of leridistim with that of filgrastim to reduce side effects in older patients who are receiving cytarabine and daunorubicin for acute myeloid leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of leridistim with that of filgrastim to reduce side effects in older patients who are receiving cytarabine and daunorubicin for acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose or hematopoietically active dose of leridistim administered with induction chemotherapy in older patients with acute myeloid leukemia II Determine the effect of leridistim on the duration of grade IV neutropenia during the induction course in these patients III Determine the safety and tolerability of leridistim in these patients IV Compare the effect of leridistim vs filgrastim G-CSF on the duration of thrombocytopenia the incidence of infection and the need for IV antibiotics in these patients V Compare the effect of leridistim vs G-CSF on the number of days of platelet andor red blood cell transfusions in these patients
OUTLINE This is a dose escalation study of leridistim and then a randomized open label multicenter study Patients are randomized to one of two treatment arms All patients receive induction chemotherapy consisting of daunorubicin IV over 15-30 minutes on days 1-3 and cytarabine IV continuously on days 1-7 Patients who do not achieve aplasia after one induction course may receive a second course Dose Escalation Phase Patients receive leridistim subcutaneously SQ every other day beginning on day 11-14 and continuing for 42 days or until blood counts recover Cohorts of 6 patients receive escalating doses of leridistim until the maximum tolerated dose MTD or hematopoietically active dose HAD has been determined The MTD is defined as the dose prior to the dose level at which at least 2 of the same dose limiting toxicities occur in different patients Consolidation Phase Patients then receive consolidation chemotherapy consisting of cytarabine IV over 1 hour every 12 hours patients 70 years and under or every 24 hours patients over 70 years on days 1-6 Beginning 24-48 hours after completion of consolidation chemotherapy patients receive leridistim as above Randomized Phase Eligible patients will receive induction and consolidation chemotherapy as outlined above Then patients are randomized to one of two treatments Arm I Patients receive leridistim SQ every other day for up to 42 days or until blood counts recover Arm II Patients receive filgrastim G-CSF SQ daily for up to 42 days or until blood counts recover Patients are followed at day 30 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 86 patients 36 for phase I and 50 for phase II will be accrued for this study
OUTLINE This is a dose escalation study of leridistim and then a randomized open label multicenter study Patients are randomized to one of two treatment arms All patients receive induction chemotherapy consisting of daunorubicin IV over 15-30 minutes on days 1-3 and cytarabine IV continuously on days 1-7 Patients who do not achieve aplasia after one induction course may receive a second course Dose Escalation Phase Patients receive leridistim subcutaneously SQ every other day beginning on day 11-14 and continuing for 42 days or until blood counts recover Cohorts of 6 patients receive escalating doses of leridistim until the maximum tolerated dose MTD or hematopoietically active dose HAD has been determined The MTD is defined as the dose prior to the dose level at which at least 2 of the same dose limiting toxicities occur in different patients Consolidation Phase Patients then receive consolidation chemotherapy consisting of cytarabine IV over 1 hour every 12 hours patients 70 years and under or every 24 hours patients over 70 years on days 1-6 Beginning 24-48 hours after completion of consolidation chemotherapy patients receive leridistim as above Randomized Phase Eligible patients will receive induction and consolidation chemotherapy as outlined above Then patients are randomized to one of two treatments Arm I Patients receive leridistim SQ every other day for up to 42 days or until blood counts recover Arm II Patients receive filgrastim G-CSF SQ daily for up to 42 days or until blood counts recover Patients are followed at day 30 and then at 6 and 12 months
PROJECTED ACCRUAL A total of 86 patients 36 for phase I and 50 for phase II will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1652 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067436 | REGISTRY | None | None |
| MCC-11506 | None | None | None |
| SC-IN5-99-12-011 | None | None | None |