Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067028
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2003-08-08
Brief Title:
Clofarabine Combinations in RelapsedRefractory Acute Myeloid Leukemia AML Myelodysplastic Syndromes MDS and Myeloid Blast Phase Chronic Myeloid Leukemia CML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Prospective Randomized Phase III Study of Clofarabine Clo and Ara-C vs Clo and Ida vs Clo Plus Ida and Ara-C in Patients With First Relapse or First Salvage of Primary Refractory AML and High-Grade MDS 10 Blasts or CML in Myeloid Blasts Phase as Front Line Therapy or in First Salvage
Status:
COMPLETED
Status Verified Date:
2020-12
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 is to compare the drug combinations clofarabineidarubicinara-C clofarabineara-C and clofarabineidarubicin in the treatment of patients with Acute Myeloid Leukemia high-grade MDS or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy
Detailed Description:
Clofarabine is a new drug that was designed to help treat leukemia Ara-C and idarubicin are drugs that are commonly used to help treat leukemia
Before treatment starts you will be asked questions about your medical history and have a complete physical exam You will have blood samples about 1 tablespoon collected for routine lab tests You will either have an echocardiogram or a multiple-gated acquisition MUGA scan to check on the function of your heart You will have a sample of bone marrow collected to check on the status of the disease To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test
After each cycle of therapy you will not receive the next cycle of chemotherapy until your blood counts have recovered and any possible side effects have gone away for around 3 to 6 weeks If the disease gets worse or side effects become too severe treatment will stop You must stay in Houston for the first 4 to 6 weeks average of treatment and are required to return to Houston to receive each additional cycle of chemotherapy up to 6 days each cycle
You will be assigned to receive treatment with clofarabine plus idarubicin and ara-C
For participants in the clofarabineidarubicinara-C group the clofarabine will be given by vein over 1 hour once a day for 5 days in a row on Days 2 to 6 of each cycle Idarubicin will be given by vein over 30 minutes for 3 days in a row on Days 1 to 3 of each cycle Ara-C will be given by vein over 2 hours for 5 days in a row on Days 1 to 5 of each cycle Idarubicin is usually started around 1 hour after the completion of clofarabine and ara-C about 4 hours after the start of the clofarabine infusion This 6 day period is called a cycle of chemotherapy
You will receive at least 1 cycle of therapy If after 1 or 2 cycles of therapy it is found that the disease is responding to therapy you may continue to receive therapy for up to 4 additional courses of consolidation therapy During the consolidation therapy you will also be given treatment courses with ara-C alone When ara-C is given alone it will be given as a continuous infusion 24 hours a day for 5 days in a row You will be given a portable pump so that this treatment can be done as an outpatient The combination drug courses and the ara-C courses will alternate ara-C alone combination ara-C alone combination for a total of 4 courses If it is found that the disease is not responding to chemotherapy you will be taken off the study and your doctor will discuss other treatment options with you
Before you receive each dose of drugs you will have a complete physical exam During treatment you will have blood about 1 tablespoon collected at least once a week during the first 2 courses of therapy then every 2-4 weeks after Bone marrow samples will be collected every other week during treatment to check on the status of the disease The blood and bone marrow samples may be collected more often if your doctor feels it is necessary
If at any time the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
After your last course of treatment you will have a follow-up visit scheduled At this visit you will have blood about 1 tablespoon collected for routine tests You will have a sample of bone marrow collected to check on the status of the disease You will also have a repeat echocardiogram or MUGA scan to check on the function of your heart
This is an investigational study Clofarabine has been authorized by the FDA to be used in research only Idarubicin and ara-C are both FDA approved and are commercially available Up to 120 participants will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will be asked questions about your medical history and have a complete physical exam You will have blood samples about 1 tablespoon collected for routine lab tests You will either have an echocardiogram or a multiple-gated acquisition MUGA scan to check on the function of your heart You will have a sample of bone marrow collected to check on the status of the disease To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle Women who are able to have children must have a negative blood or urine pregnancy test
After each cycle of therapy you will not receive the next cycle of chemotherapy until your blood counts have recovered and any possible side effects have gone away for around 3 to 6 weeks If the disease gets worse or side effects become too severe treatment will stop You must stay in Houston for the first 4 to 6 weeks average of treatment and are required to return to Houston to receive each additional cycle of chemotherapy up to 6 days each cycle
You will be assigned to receive treatment with clofarabine plus idarubicin and ara-C
For participants in the clofarabineidarubicinara-C group the clofarabine will be given by vein over 1 hour once a day for 5 days in a row on Days 2 to 6 of each cycle Idarubicin will be given by vein over 30 minutes for 3 days in a row on Days 1 to 3 of each cycle Ara-C will be given by vein over 2 hours for 5 days in a row on Days 1 to 5 of each cycle Idarubicin is usually started around 1 hour after the completion of clofarabine and ara-C about 4 hours after the start of the clofarabine infusion This 6 day period is called a cycle of chemotherapy
You will receive at least 1 cycle of therapy If after 1 or 2 cycles of therapy it is found that the disease is responding to therapy you may continue to receive therapy for up to 4 additional courses of consolidation therapy During the consolidation therapy you will also be given treatment courses with ara-C alone When ara-C is given alone it will be given as a continuous infusion 24 hours a day for 5 days in a row You will be given a portable pump so that this treatment can be done as an outpatient The combination drug courses and the ara-C courses will alternate ara-C alone combination ara-C alone combination for a total of 4 courses If it is found that the disease is not responding to chemotherapy you will be taken off the study and your doctor will discuss other treatment options with you
Before you receive each dose of drugs you will have a complete physical exam During treatment you will have blood about 1 tablespoon collected at least once a week during the first 2 courses of therapy then every 2-4 weeks after Bone marrow samples will be collected every other week during treatment to check on the status of the disease The blood and bone marrow samples may be collected more often if your doctor feels it is necessary
If at any time the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
After your last course of treatment you will have a follow-up visit scheduled At this visit you will have blood about 1 tablespoon collected for routine tests You will have a sample of bone marrow collected to check on the status of the disease You will also have a repeat echocardiogram or MUGA scan to check on the function of your heart
This is an investigational study Clofarabine has been authorized by the FDA to be used in research only Idarubicin and ara-C are both FDA approved and are commercially available Up to 120 participants will take part in this study All will be enrolled at M D 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