Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01515527
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2012-01-13
Brief Title:
Cladribine Plus Low Dose Cytarabine LDAC Alternating With Decitabine in Patients With Acute Myeloid Leukemia AML or High-Risk Myelodysplastic Syndrome MDS
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Cladribine Plus Low Dose Cytarabine LDAC Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia AML or High-Risk Myelodysplastic Syndrome MDS
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine LDAC and decitabine can help control the disease in patients with AML or MDS The safety of this drug combination will also be studied
Cladribine is designed to interfere with the cells ability to process DNA the genetic material of cells It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves
Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves
Decitabine is designed to damage the DNA of cells which may cause cancer cells to die
This is an investigational study Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia Its use in patients with AML is investigational
Cytarabine is FDA approved and commercially available for use in patients with AML
Decitabine is FDA approved and commercially available for use in patients with MDS Its use for patients with AML is investigational
Up to 160 patients will take part in this study All will be enrolled at MD Anderson
Cladribine is designed to interfere with the cells ability to process DNA the genetic material of cells It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves
Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves
Decitabine is designed to damage the DNA of cells which may cause cancer cells to die
This is an investigational study Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia Its use in patients with AML is investigational
Cytarabine is FDA approved and commercially available for use in patients with AML
Decitabine is FDA approved and commercially available for use in patients with MDS Its use for patients with AML is investigational
Up to 160 patients will take part in this study All will be enrolled at MD Anderson
Detailed Description:
Study Drug Administration
If you are eligible to take part in this study you will receive 1 or 2 cycles of induction therapy followed by up to 17 cycles of consolidation therapy Each study cycle is 4 weeks
Induction Cycles
On Days 1-5 you will receive cladribine by vein over 1-2 hours
On Days 1-10 you will give yourself the cytarabine by injection twice a day about 12 hours apart You will receive instructions on how give yourself the injections
You may receive up to 2 cycles at this dose and schedule
Consolidation Cycles
Consolidation cycles will begin on Cycle 2 regardless of how many cycles you received of induction therapy
During Cycles 2 5 6 9 10 13 14 17 and 18
On Days 1-3 you will receive cladribine by vein over 1-2 hours
On Days 1-10 you will give yourself cytarabine by injection twice daily starting 3 to 6 hours after the start of the cladribine infusion
Cycles 3 4 7 8 11 12 15 and 16
On Days 1-5 you will receive decitabine by vein over 1-2 hours each day
Length of Treatment
You may continue taking the study drugs for up to 18 cycles You will no longer be able to take the study drug if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over when you have completed follow-up
Study Visits
On Day 1 of every cycle
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
On Day 21 - 7days of the induction cycle you may have a bone marrow aspirate to check the status of the disease After that you will have a bone marrow aspirate every 2 weeks or more often if your doctor feels it is necessary If your routine blood tests show that there is still leukemia you may not need to have the bone marrow samples collected
Blood about 1-2 teaspoons will be drawn for routine tests at least 1 time weekly until remission then every 2-4 weeks during treatment the every 4-8 weeks while you are on the study
Follow-Up Visits
When you are off treatment every 6 -12 months you will be contacted by a member of the study staff You will be asked about any side effects you may be having The phone calls will take about 5-10 minutes You will continue to be called for as long as possible
If you are eligible to take part in this study you will receive 1 or 2 cycles of induction therapy followed by up to 17 cycles of consolidation therapy Each study cycle is 4 weeks
Induction Cycles
On Days 1-5 you will receive cladribine by vein over 1-2 hours
On Days 1-10 you will give yourself the cytarabine by injection twice a day about 12 hours apart You will receive instructions on how give yourself the injections
You may receive up to 2 cycles at this dose and schedule
Consolidation Cycles
Consolidation cycles will begin on Cycle 2 regardless of how many cycles you received of induction therapy
During Cycles 2 5 6 9 10 13 14 17 and 18
On Days 1-3 you will receive cladribine by vein over 1-2 hours
On Days 1-10 you will give yourself cytarabine by injection twice daily starting 3 to 6 hours after the start of the cladribine infusion
Cycles 3 4 7 8 11 12 15 and 16
On Days 1-5 you will receive decitabine by vein over 1-2 hours each day
Length of Treatment
You may continue taking the study drugs for up to 18 cycles You will no longer be able to take the study drug if the disease gets worse if intolerable side effects occur or if you are unable to follow study directions
Your participation on the study will be over when you have completed follow-up
Study Visits
On Day 1 of every cycle
You will have a physical exam including measurement of your weight and vital signs
Your performance status will be recorded
On Day 21 - 7days of the induction cycle you may have a bone marrow aspirate to check the status of the disease After that you will have a bone marrow aspirate every 2 weeks or more often if your doctor feels it is necessary If your routine blood tests show that there is still leukemia you may not need to have the bone marrow samples collected
Blood about 1-2 teaspoons will be drawn for routine tests at least 1 time weekly until remission then every 2-4 weeks during treatment the every 4-8 weeks while you are on the study
Follow-Up Visits
When you are off treatment every 6 -12 months you will be contacted by a member of the study staff You will be asked about any side effects you may be having The phone calls will take about 5-10 minutes You will continue to be called for as long as possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2012-00145 | REGISTRY | NCI CTRP | None |