Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT01515527|
Recruitment Status : Recruiting
First Posted : January 24, 2012
Last Update Posted : March 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Cladribine Drug: Cytarabine Drug: Decitabine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 2012|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: Cladribine + Cytarabine Alt. with Decitabine
Induction cycle: Cladribine intravenous (IV) over approximately 1 to 2 hours, daily on days 1-5 combined with Cytarabine subcutaneous (SQ) twice daily on days 1-10. Cytarabine should be administered approximately 3-6 hours following the start of the cladribine infusion.
Consolidation cycle: Cladribine IV over 1 to 2 hours, daily on days 1-3 combined with Cytarabine SQ twice daily on days 1-10. Cytarabine should be administered 3-6 hours following the start of the cladribine infusion.
Alternating with: Decitabine IV over 1 to 2 hours, daily on days 1-5.
Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles.
Consolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.
Other Names:Drug: Cytarabine
Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles.
Consolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.
Other Names:Drug: Decitabine
Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.
Other Name: Dacogen
- Disease-Free Survival (DFS) [ Time Frame: Day 21 ]Disease-free survival (DFS) defined as the time interval from treatment start until clinically significant disease progression or death, whichever occurred first. Participants followed for survival every 6 to 12 months after completion of active treatment. Study continuously monitored for primary endpoint, DFS using the method of Thall, Wooten, and Tannir.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515527
|Contact: Tapan Kadia, MD||713-563-3534|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tapan Kadia, MD||M.D. Anderson Cancer Center|