Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038610
Status:
COMPLETED
Last Update Posted:
2015-09-18
First Post:
2002-06-03
Brief Title:
Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Hyper-CVAD Plus Imatinib Mesylate Gleevec STI571 for Philadelphia-Positive Acute Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2015-08
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:
The goal of this clinical research study is to learn if intensive chemotherapy combined with imatinib mesylate Gleevec STI571 given for 8 courses over 6 months followed by maintenance imatinib mesylate plus chemotherapy for 2 years followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia The safety of this treatment will also be studied
Detailed Description:
Before treatment starts patients will have a complete exam including medical history and documentation of disease blood and marrow tests A chest x-ray will be taken CT scans may be taken if needed A bone marrow sample will be taken through a large needle An EKG and MUGA heart function tests will be performed
During treatment patients will give blood samples about 1 tablespoon each at least twice a week A bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check on response After two courses of chemotherapy the tests done before treatment will be repeated to check for response
All patients will receive 2 kinds of chemotherapy courses for a total of 8 courses Chemotherapy courses will be given through a large vein by a central venous catheter a plastic tube usually placed under the collarbone Imatinib mesylate will be given as a pill with the chemotherapy
Course 1 will start with cyclophosphamide given by vein over 2-3 hours every 12 hours for 6 doses over 3 days Days 123 Mesna will be given by vein continuously for 4 days with the cyclophosphamide to protect the bladder Doxorubicin will be given by vein over 24 hours on Day 4 Vincristine will be given by short infusion on Days 4 and 11 Dexamethasone a steroid will be given by mouth or by vein on Days 1-4 and 11-14 The imatinib mesylate will be given by mouth with breakfast and a large glass of water daily on Days 1-14 Medicines will be given to prevent nausea and to protect the kidneys from increased amounts of uric acid which may be released when leukemia cells die
G-CSF growth stimulating colony factor will be given after completion of the chemotherapy It is given to allow for rapid recovery of the normal marrow G-CSF will be injected under the skin until the counts recover Treatment to the brain will be given inside the spinal fluid with methotrexate around Day 2 and cytarabine about day 7 This is done to prevent the leukemia from developing there
For patients aged 60 years or older this Course 1 will be given in a protective isolation room to decrease the risk of infections
During Course 2 patients will be given methotrexate by infusion over 24 hours on the first day and cytarabine at a high dose over 2 hours every 12 hours for 4 doses Days 2 and 3 Citrovorum factor leucovorin an antidote for side effects of methotrexate will be given by vein or by mouth for 2-3 days Day 2 and on Solumedrol a steroid will be given by vein every 12 hours for 6 doses Imatinib mesylate will be given by mouth with breakfast and a large glass of water on Days 1-14 or daily depending on tolerance with Course 1 G-CSF will be given as in Course 1 The treatment to the brain inside the spinal fluid will be given as in Course 1 around Days 2 and 7
The chemotherapy will alternate between hyper-CVAD plus imatinib mesylate Courses 1 3 5 and 7 and methotrexatecytarabine plus imatinib mesylate Courses 2 4 6 and 8 to complete a total of 8 courses G-CSF will be given as in Course 1 Anti-nausea medicine will be given with each course of chemotherapy The urine will be alkalized to protect the kidneys Antibiotics will be given by mouth to prevent infection
After the 8 courses monthly maintenance chemotherapy plus imatinib mesylate will be given This includes daily imatinib mesylate monthly vincristine by vein and prednisone by mouth for 5 days every month Maintenance chemotherapy will be given for a total of 24 months and will be interrupted by 2 periods of intensive chemotherapy courses with hyper-CVAD and imatinib mesylate at 6 and 13 months from the start of maintenance Imatinib mesylate will be continued daily as tolerated indefinitely
After two courses of the intensive chemotherapy the response to the treatment will be evaluated If the leukemia is responding the therapy will be continued Patients will be taken off study if the leukemia starts to get worse
During and after completion of treatment patients will have a complete exam including blood tests If needed a chest X-ray or CT scan will be done A bone marrow sample will be taken through a large needle Patients will then return every 2 to 3 months for a checkup including blood and bone marrow X-rays and heart studies MUGA or ECG may be repeated if needed
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to prevent leukemia in patients who have difficulty with the spinal treatments An Ommaya reservoir is an access port inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain
Treatment will be given on an inpatient basis 3 to 5 days for the 8 intensive courses of chemotherapy or as indicated by the clinical condition The maintenance treatments will be given as an outpatient except for the courses of hyper-CVAD and imatinib mesylate
This is an investigational study The FDA has approved imatinib mesylate for use in chronic myelogenous leukemia and other clinical research studies About 55 patients will take part in this study All will be from MD Anderson
During treatment patients will give blood samples about 1 tablespoon each at least twice a week A bone marrow sample will be repeated 2 and 3 weeks from the beginning of treatment to check on response After two courses of chemotherapy the tests done before treatment will be repeated to check for response
All patients will receive 2 kinds of chemotherapy courses for a total of 8 courses Chemotherapy courses will be given through a large vein by a central venous catheter a plastic tube usually placed under the collarbone Imatinib mesylate will be given as a pill with the chemotherapy
Course 1 will start with cyclophosphamide given by vein over 2-3 hours every 12 hours for 6 doses over 3 days Days 123 Mesna will be given by vein continuously for 4 days with the cyclophosphamide to protect the bladder Doxorubicin will be given by vein over 24 hours on Day 4 Vincristine will be given by short infusion on Days 4 and 11 Dexamethasone a steroid will be given by mouth or by vein on Days 1-4 and 11-14 The imatinib mesylate will be given by mouth with breakfast and a large glass of water daily on Days 1-14 Medicines will be given to prevent nausea and to protect the kidneys from increased amounts of uric acid which may be released when leukemia cells die
G-CSF growth stimulating colony factor will be given after completion of the chemotherapy It is given to allow for rapid recovery of the normal marrow G-CSF will be injected under the skin until the counts recover Treatment to the brain will be given inside the spinal fluid with methotrexate around Day 2 and cytarabine about day 7 This is done to prevent the leukemia from developing there
For patients aged 60 years or older this Course 1 will be given in a protective isolation room to decrease the risk of infections
During Course 2 patients will be given methotrexate by infusion over 24 hours on the first day and cytarabine at a high dose over 2 hours every 12 hours for 4 doses Days 2 and 3 Citrovorum factor leucovorin an antidote for side effects of methotrexate will be given by vein or by mouth for 2-3 days Day 2 and on Solumedrol a steroid will be given by vein every 12 hours for 6 doses Imatinib mesylate will be given by mouth with breakfast and a large glass of water on Days 1-14 or daily depending on tolerance with Course 1 G-CSF will be given as in Course 1 The treatment to the brain inside the spinal fluid will be given as in Course 1 around Days 2 and 7
The chemotherapy will alternate between hyper-CVAD plus imatinib mesylate Courses 1 3 5 and 7 and methotrexatecytarabine plus imatinib mesylate Courses 2 4 6 and 8 to complete a total of 8 courses G-CSF will be given as in Course 1 Anti-nausea medicine will be given with each course of chemotherapy The urine will be alkalized to protect the kidneys Antibiotics will be given by mouth to prevent infection
After the 8 courses monthly maintenance chemotherapy plus imatinib mesylate will be given This includes daily imatinib mesylate monthly vincristine by vein and prednisone by mouth for 5 days every month Maintenance chemotherapy will be given for a total of 24 months and will be interrupted by 2 periods of intensive chemotherapy courses with hyper-CVAD and imatinib mesylate at 6 and 13 months from the start of maintenance Imatinib mesylate will be continued daily as tolerated indefinitely
After two courses of the intensive chemotherapy the response to the treatment will be evaluated If the leukemia is responding the therapy will be continued Patients will be taken off study if the leukemia starts to get worse
During and after completion of treatment patients will have a complete exam including blood tests If needed a chest X-ray or CT scan will be done A bone marrow sample will be taken through a large needle Patients will then return every 2 to 3 months for a checkup including blood and bone marrow X-rays and heart studies MUGA or ECG may be repeated if needed
An Ommaya reservoir may also be placed surgically as a route to treat leukemia in the brain or to prevent leukemia in patients who have difficulty with the spinal treatments An Ommaya reservoir is an access port inserted under the skin of the scalp that enters into the spinal fluid cavity of the brain
Treatment will be given on an inpatient basis 3 to 5 days for the 8 intensive courses of chemotherapy or as indicated by the clinical condition The maintenance treatments will be given as an outpatient except for the courses of hyper-CVAD and imatinib mesylate
This is an investigational study The FDA has approved imatinib mesylate for use in chronic myelogenous leukemia and other clinical research studies About 55 patients will take part in this study All will be from MD Anderson
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-2012-01487 | REGISTRY | NCI CTRP | None |