Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003700
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction and Cytarabine During Consolidation Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation
Status:
COMPLETED
Status Verified Date:
2016-07
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine the complete response rate and toxicity of escalating doses of daunorubicin in patients under 60 years old with untreated acute lymphoblastic leukemia ALL
Determine the complete response rate and toxicity of a constant dose of daunorubicin in patients at least 60 years old with untreated ALL
Determine the toxicity of high dose cytarabine during postremission therapy in these patients
Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and high-dose intravenous chemotherapy replace cranial irradiation
OUTLINE
Course I Patients are assigned to 1 of 2 induction treatment groups based on age
Group 1 under age 60 Patients receive cyclophosphamide IV over 15-30 minutes on day 1 escalating doses of daunorubicin IV over 5-10 minutes on days 1-3 vincristine IV on days 1 8 15 and 22 oral prednisone on days 1-21 asparaginase intramuscularly on days 5 8 11 15 18 and 22 and filgrastim G-CSF subcutaneously SC beginning on day 4 and continuing for at least 7 days and then until blood counts recover
Group 2 age 60 and over Patients receive vincristine asparaginase cyclophosphamide and G-CSF as in group 1 fixed dose daunorubicin IV over 5-10 minutes on days 1-3 and oral prednisone on days 1-7
Patients are then evaluated for bone marrow cellularity on day 29 Those with M0 M1 or M2 cellularity proceed to course II Patients with M3 cellularity may proceed to course II or be removed from study
Course II early intensification Patients receive intrathecal methotrexate and cyclophosphamide IV over 15-30 minutes on day 1 cytarabine IV over 3 hours on days 1-3 and G-CSF SC beginning on day 4
Bone marrow is again examined on day 29 Patients with M0 or M1 cellularity after course I and no sign of relapse after course II proceed to course III Patients with M2 or M3 cellularity after course I must have M0 or M1 cellularity after course II to proceed to course III Patients with M2 or M3 cellularity after course II are removed from study
Course III Patients receive intrathecal methotrexate vincristine IV and methotrexate IV over 3 hours on days 1 8 and 15 and oral methotrexate every 6 hours for 4 doses beginning 6 hours after starting methotrexate IV on days 1 2 8 9 15 and 16 Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on days 2 9 and 16 and oral leucovorin calcium beginning 12 hours after leucovorin calcium IV for at least 4 doses on days 3 4 10 11 17 and 18
Patients must be off leucovorin calcium for a minimum of 3 days before beginning days 8 and 15 of treatment Patients who maintain M0 or M1 cellularity on day 29 of course III continue therapy Those with M2 or M3 cellularity after course III are removed from the study
Course IV Late intensification Repeat course I
Course V Late intensification Repeat course II
Course VI CNS intensification Repeat course III
Course VII Prolonged maintenance Patients receive oral mercaptopurine daily vincristine IV once every 4 weeks oral prednisone on days 1-5 and oral methotrexate on days 1 8 15 and 22 Courses repeat every 4 weeks for up to 18 months
Patients with testicular disease receive gonadal radiotherapy anytime after course I Chemotherapy is not halted during radiotherapy
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for 10 years
PROJECTED ACCRUAL A total of 140 patients will be accrued for this study within 15 months
Determine the complete response rate and toxicity of escalating doses of daunorubicin in patients under 60 years old with untreated acute lymphoblastic leukemia ALL
Determine the complete response rate and toxicity of a constant dose of daunorubicin in patients at least 60 years old with untreated ALL
Determine the toxicity of high dose cytarabine during postremission therapy in these patients
Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and high-dose intravenous chemotherapy replace cranial irradiation
OUTLINE
Course I Patients are assigned to 1 of 2 induction treatment groups based on age
Group 1 under age 60 Patients receive cyclophosphamide IV over 15-30 minutes on day 1 escalating doses of daunorubicin IV over 5-10 minutes on days 1-3 vincristine IV on days 1 8 15 and 22 oral prednisone on days 1-21 asparaginase intramuscularly on days 5 8 11 15 18 and 22 and filgrastim G-CSF subcutaneously SC beginning on day 4 and continuing for at least 7 days and then until blood counts recover
Group 2 age 60 and over Patients receive vincristine asparaginase cyclophosphamide and G-CSF as in group 1 fixed dose daunorubicin IV over 5-10 minutes on days 1-3 and oral prednisone on days 1-7
Patients are then evaluated for bone marrow cellularity on day 29 Those with M0 M1 or M2 cellularity proceed to course II Patients with M3 cellularity may proceed to course II or be removed from study
Course II early intensification Patients receive intrathecal methotrexate and cyclophosphamide IV over 15-30 minutes on day 1 cytarabine IV over 3 hours on days 1-3 and G-CSF SC beginning on day 4
Bone marrow is again examined on day 29 Patients with M0 or M1 cellularity after course I and no sign of relapse after course II proceed to course III Patients with M2 or M3 cellularity after course I must have M0 or M1 cellularity after course II to proceed to course III Patients with M2 or M3 cellularity after course II are removed from study
Course III Patients receive intrathecal methotrexate vincristine IV and methotrexate IV over 3 hours on days 1 8 and 15 and oral methotrexate every 6 hours for 4 doses beginning 6 hours after starting methotrexate IV on days 1 2 8 9 15 and 16 Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on days 2 9 and 16 and oral leucovorin calcium beginning 12 hours after leucovorin calcium IV for at least 4 doses on days 3 4 10 11 17 and 18
Patients must be off leucovorin calcium for a minimum of 3 days before beginning days 8 and 15 of treatment Patients who maintain M0 or M1 cellularity on day 29 of course III continue therapy Those with M2 or M3 cellularity after course III are removed from the study
Course IV Late intensification Repeat course I
Course V Late intensification Repeat course II
Course VI CNS intensification Repeat course III
Course VII Prolonged maintenance Patients receive oral mercaptopurine daily vincristine IV once every 4 weeks oral prednisone on days 1-5 and oral methotrexate on days 1 8 15 and 22 Courses repeat every 4 weeks for up to 18 months
Patients with testicular disease receive gonadal radiotherapy anytime after course I Chemotherapy is not halted during radiotherapy
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually for 10 years
PROJECTED ACCRUAL A total of 140 patients will be accrued for this study within 15 months
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 | None |
| CDR0000066807 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |