Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01515527
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2012-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
M.D. Anderson Cancer Center
Organization:
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:
2025-08
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 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 cell's 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 cell's 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00145 | REGISTRY | NCI CTRP | View |