Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422591
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2007-01-16
Brief Title:
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia AML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine ara-C can help to control AML
Objectives
To determine the complete response CR rate event-free survival EFS and overall survival OS of patients with newly diagnosed acute myeloid leukemia AML receiving standard combination chemotherapy with Idarubicin and cytarabine
Objectives
To determine the complete response CR rate event-free survival EFS and overall survival OS of patients with newly diagnosed acute myeloid leukemia AML receiving standard combination chemotherapy with Idarubicin and cytarabine
Detailed Description:
Ara-C and idarubicin are designed to interfere with DNAs the genetic material of cells ability to repair itself causing cancer cells to die
If you are found to be eligible to take part in this study you will receive treatment with idarubicin and ara-C for up to 8 cycles One cycle lasts about 4-5 weeks Cycles 1 and 2 are called induction therapy which is used to help induce cause a remission Cycles 3 to 8 are called consolidation therapy which is a type of high-dose chemotherapy often given as the second phase of a cancer treatment
After Cycle 1 you will have a brief rest period of a few days before you move on to Cycle 2 On Day 1 of Cycle 1 you will receive cytarabine by vein as a continuous infusion over 4 days It will only be 3 days if you are age 60 or older On Days 1-3 of Cycle 1 you will receive idarubicin by vein over 1 hour once a day
The dose of the study drugs you receive may be changed to help manage side effects such as nausea and diarrhea that you may experience Medications given by mouth or by vein such as Tylenol acetaminophen may be given before and during treatment to help decrease the risk of such side effects The study doctor will specify what these medications are
You will have blood drawn about 2 teaspoons for routine tests about once a week during treatment Starting on Days 21-28 you will have bone marrow collected every 1-2 weeks to check the status of the disease Blood about 2 tablespoons will also be drawn at least twice a week after each cycle of therapy beginning about 4-6 weeks from the start of treatment each cycle to check your blood counts
Cycle 2 will begin after your blood counts have recovered If at the end of Cycle 1 you have not achieved a remission disease has decreased you may receive Cycle 2 which will be similar to Cycle 1
If the disease is responding to treatment after Cycle 2 after completion of induction therapy you will receive up to 6 more cycles of therapy These cycles are called consolidation therapy Consolidation therapy is a type of high-dose chemotherapy often given as the second phase to treat cancer For consolidation therapy you will receive ara-C as a continuous infusion over 3 days starting on Day 1 of Cycle 3 On Days 1 and 2 of Cycles 3 and 4 you will receive idarubicin by vein over 1 hour Your blood about 2 tablespoons will be drawn at least twice a week after each cycle to check your blood counts Cycle 3 will begin after your blood counts have recovered
After completion of consolidation therapy you may receive what is called maintenance therapy Maintenance therapy will start after completion of consolidation therapy Maintenance therapy is often given to help keep cancer in remission It is treatment that is given to help the original treatment keep working You will be told if you will have maintenance therapy as well as the drugs and drug schedule you will be on
During consolidation andor maintenance therapy blood about 2 teaspoons will be drawn for routine tests every 1-2 weeks You will have bone marrow collected every 3-6 months to check the status of the disease
You may have treatment on this study for up to 8 cycles induction and consolidation therapy or more for maintenance therapy depending on disease response to the study drugs If the disease gets worse or you experience any intolerable side effects you will be taken off this study and your study doctor will discuss other treatment options with you
Once your participation is over on this study you will be followed-up with a phone call by the study doctor or study nurse to check on how you are doing and if you have experienced any intolerable side effects The call should last about 10-15 minutes
This is an investigational study Idarubicin and ara-C are both FDA approved and commercially available Up to 200 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will receive treatment with idarubicin and ara-C for up to 8 cycles One cycle lasts about 4-5 weeks Cycles 1 and 2 are called induction therapy which is used to help induce cause a remission Cycles 3 to 8 are called consolidation therapy which is a type of high-dose chemotherapy often given as the second phase of a cancer treatment
After Cycle 1 you will have a brief rest period of a few days before you move on to Cycle 2 On Day 1 of Cycle 1 you will receive cytarabine by vein as a continuous infusion over 4 days It will only be 3 days if you are age 60 or older On Days 1-3 of Cycle 1 you will receive idarubicin by vein over 1 hour once a day
The dose of the study drugs you receive may be changed to help manage side effects such as nausea and diarrhea that you may experience Medications given by mouth or by vein such as Tylenol acetaminophen may be given before and during treatment to help decrease the risk of such side effects The study doctor will specify what these medications are
You will have blood drawn about 2 teaspoons for routine tests about once a week during treatment Starting on Days 21-28 you will have bone marrow collected every 1-2 weeks to check the status of the disease Blood about 2 tablespoons will also be drawn at least twice a week after each cycle of therapy beginning about 4-6 weeks from the start of treatment each cycle to check your blood counts
Cycle 2 will begin after your blood counts have recovered If at the end of Cycle 1 you have not achieved a remission disease has decreased you may receive Cycle 2 which will be similar to Cycle 1
If the disease is responding to treatment after Cycle 2 after completion of induction therapy you will receive up to 6 more cycles of therapy These cycles are called consolidation therapy Consolidation therapy is a type of high-dose chemotherapy often given as the second phase to treat cancer For consolidation therapy you will receive ara-C as a continuous infusion over 3 days starting on Day 1 of Cycle 3 On Days 1 and 2 of Cycles 3 and 4 you will receive idarubicin by vein over 1 hour Your blood about 2 tablespoons will be drawn at least twice a week after each cycle to check your blood counts Cycle 3 will begin after your blood counts have recovered
After completion of consolidation therapy you may receive what is called maintenance therapy Maintenance therapy will start after completion of consolidation therapy Maintenance therapy is often given to help keep cancer in remission It is treatment that is given to help the original treatment keep working You will be told if you will have maintenance therapy as well as the drugs and drug schedule you will be on
During consolidation andor maintenance therapy blood about 2 teaspoons will be drawn for routine tests every 1-2 weeks You will have bone marrow collected every 3-6 months to check the status of the disease
You may have treatment on this study for up to 8 cycles induction and consolidation therapy or more for maintenance therapy depending on disease response to the study drugs If the disease gets worse or you experience any intolerable side effects you will be taken off this study and your study doctor will discuss other treatment options with you
Once your participation is over on this study you will be followed-up with a phone call by the study doctor or study nurse to check on how you are doing and if you have experienced any intolerable side effects The call should last about 10-15 minutes
This is an investigational study Idarubicin and ara-C are both FDA approved and commercially available Up to 200 patients will take part in this study All will be enrolled at 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-2012-01412 | REGISTRY | NCI CTRP | None |